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Based on review of medical records, policy and procedures and staff interviews the hospital failed to follow their policy and procedure for obtaining consents as evidenced by: 1) the anesthesiologist or his/her designee failing to obtain an informed consent for anesthesia to be administered for a scheduled invasive procedure (#13) for 1 of 5 records reviewed with surgical/invasive procedures; 2) a physician failing to obtain a consent for a scheduled arterial catherization (#13) for 1 of 5 records reviewed with surgical/invasive procedures reviewed; and 3) the admission department failing to obtain consent for treatment at the time of admit (#23) for 1 of 34 sampled medical records with the potential to effect the rights of all patients admitted to the hospital. Findings:

1) anesthesia failing to obtain an informed consent for anesthesia to be administered for a scheduled invasive procedure
Review of the "consent to Medical Treatment Form" dated/timed 07/06/10 at 0640 (6:40am) for Patient #13 revealed the description, nature of the treatment/procedure: General/Epidural/Spinal Regional/Monitored Anesthesia Care (MAC); however there was no documented evidence of which form of anesthesia that was to be used for the procedure. Further review revealed no documented evidence the physician/anesthesiologist had provided the informed consent to the Patient #13 as evidenced by a blank in the space provided for the signature of the physician.

2) physician failing to obtain a consent for a scheduled arterial catherization
Review of the consent form for Arterial Catherization and Central Venous and Pulmonary Artery Catherization dated/timed 0640 (6:40am) for Patient #13 revealed no documented evidence the physician had given the informed consent to the Patient #13 as evidenced by a blank in the space provided for the signature of the physician.

In a face to face interview on 07/07/10 at 1:55pm S17, RN Surgical Services Educator indicated if the appropriate consents have not been signed, the pre-op nurse should prevent the patient without the appropriate consents from leaving the holding area. Further S17 indicated the circulating nurse assigned to the patient should also check on the consents and if not appropriately executed make sure all of the signatures have been obtained before the patient is brought to the surgery room.

Review of the Medical Staff Rules and Regulations, effective 07/07/09 revealed it was the responsibility of the physician to obtain informed consent form the patient.

3) the admission department failing to obtain consent for treatment at the time of admit Review of the medical record revealed Patient #23 had been admitted to the hospital on 07/06/10 from a group home with the complaint of having a large bloody bowel movement. Further review revealed she had a history of mental insufficiency and at the time of admit was alone and not capable of consenting to treatment or providing any information concerning her advanced directives.

Review of the "Request and Consent for Admission, Diagnosis and Treatment" form dated 07/06/10 for Patient #23 revealed no documented evidence the patient's family, guardian, and/or POA (Power of Attorney) had signed the document or had given consent over the phone as evidenced by a blank in the space provided on the consent for treatment form.

In a face to face interview on 07/08/10 at 10:25am S35 Admitting Manager indicated when a patient is admitted from a group home with a caregiver, the caregiver is not allowed to sign the consent for treatment. Further S35's mother was not at the hospital so they did not have anyone to sign the consent form. S35 indicated at the present time there is not a hospital policy in place for obtaining a signature when a patient is not able and a family member is not present.

Review of an incident report filed by S23's mother on 07/07/10 verified the mother of Patient #23 had been at the hospital on that date and reported to the nursing staff an incident regarding a tourniquet being left on her daughter's arm by the laboratory department staff.

In a face to face interview on 07/09/10 at 9:45am RN 18 reviewed the unsigned consent form and incident report verifying Patient #23's mother was at the hospital. S18 confirmed the hospital could and should have gotten Patient #23's mother to sign the consent for treatment form at that time.

Review of the Medical Staff Rules and Regulations, effective 07/07/09, revealed ..... 9. A general consent form, signed by or on behalf of every patient admitted to the hospital, must be obtained at the time of admission. The admitting officer should notify the attending practitioner whenever such consent has not been obtained. When so notified, it shall, except in emergency situations, be the practitioner's obligation to obtain proper consent before the patient is treated in the hospital" .

Based on review of the Quality Assurance/Performance Improvement Data for 2010, Meeting Minutes, Respiratory Department Reports and staff interviews the hospital failed to monitor medical errors as evidenced by the high volume of unreported medication variances identified by computer generated reports; the lack of a clear and accurate definition of what constitutes a medication variance in the respiratory department and whether or not it must be reported. Findings:

Review of the Quality Assurance/Performance Improvement indicators for 2010 submitted by the hospital as the one currently used by the QA/PI program revealed no documented evidence medication errors in the Respiratory Department were being monitored as part of the Hospital-wide or department specific program.

Review of the data reports submitted by the Respiratory Department for the time period of 04/01/10 through 05/15/10 and 06/01/10 through 06/15/10 revealed the hospital had the capability of tracking missed respiratory treatments via the computer even though individual variance reports had not been completed.

Review of the Respiratory Care Service Policy titled "Medication Errors" last revised/approved 03/10 and submitted by the hospital as the one currently in use revealed, ..... "A medication error is defined as any preventable medication related event that may lead to inappropriate use or cause patient harm. Such events may be related to professional practice, procedures or systems. The medication use process includes prescribing, order communication, dispensing, distributuion, administration, patient education, and monitoring response. c. Missed therapies ii. A therapy is considered missed if the respiratory therapist is not able to perform it by the end of the shift in which it is due".

Review of the Respiratory Care Service Policy titled "Respiratory Care Time Standards" last revised/approved 03/09 revealed the hospital recognized that it would not be possible to administer respiratory treatments at the times prescribed by physicians due to the fact that a single respirtory tech was assigned as many as 10-12 patients at a time. Further review of the policy revealed, ".... The therapist may stagger treatment times to keep the intervals between treatments appropriate. The general expectation is that treatments will be given within two hours before or afer the targeted treatment time".

In a face-to-face interview on 07/09/10 at 9:05am, Director of Respiratory S40 indicated an occurrence report (medication variance) is not completed by staff if a respiratory treatment is missed. She further indicated if a respiratory treatment is given late, greater than 2 hours from the ordered time, an occurrence report is completed, because that would be considered a medication error.

Based on review of the Quality Assurance/Performance Improvement Data for 2010, Meeting Minutes, Respiratory Department Reports and staff interviews the hospital failed to monitor the high volume of respiratory treatments (which is one of the main functions of the department) administered in the hospital and how missed and/or late treatments could affect health outcomes and quality of care as evidenced by the high volume of unreported medication variances, failure of the hospital to analyze available computer generated reports for missed medications and the continued non-compliance in medication administration due to the lack of corrective action taken. Findings:

Review of the Quality Assurance/Performance Improvement indicators for 2010 submitted by the hospital as the one currently used by the QA/PI program revealed no documented evidence medication errors in the Respiratory Department were being monitored as part of the Hospital-wide or department specific program.

Review of the Respiratory Policy titled "Quality Assessment and Improvement, last revised 05/07 and submitted as the one currently in use, revealed, ".... 1.5 All members of the RC staff (Respiratory Care) are expected to participate in PI (Performance Improvement), specifically in regards to reporting observed problems, contributing to resolve issues of concern, and participation in departmental/hospital PI groups".

Review of the data reports submitted by the Respiratory Department for the time period of 04/01/10 through 05/15/10 and 06/01/10 through 06/15/10 revealed the hospital had the capability of tracking missed respiratory treatments via the computer even though individual variance reports had not been completed.

In a face to face interview on 07/13/10 at 8:35am S40 Director of Respiratory Services indicated she looks at the missed treatment reports usually to talk with the therapists about the treatments being missed. Further S40 confirmed she has to data to show trends had been tracked, analyzed or corrective action taken.

Based on review of medical records, policy and procedure, respiratory reports and staff interviews the hospital failed to ensure all medical errors had been tracked and their causes analyzed as evidenced by the respiratory department's failure to monitor and report missed respiratory treatments resulting in 162 unreported variances and continued failure to ensure patients with physician orders for respiratory treatments had been administered. Findings:

Review of the Quality Assuraance/Performance Improvement indicators for 2010 submitted by the hospital as the one currently used by the QA/PI program revealed no documented evidence medication errors in the Respiratory Department were being monitored as part of the Hospital-wide or department specific program.

Review of the medical records for Patients #15, #26, R1, R3, R4, R6, R13, R15, R16, and R17 and reports generated for random time periods of 04/01/10 through 04/15/10 and 06/01/10 through 06/15/10 revealed a total of 162 missed respiratory treatments (see findings at A 1163).

In a face-to-face interview on 07/09/10 at 9:05am, Director of Respiratory S40 indicated an occurrence report (medication variance) is not completed by staff if a respiratory treatment is missed. She further indicated if a respiratory treatment is given late, greater than 2 hours from the ordered time, an occurrence report is completed, because that would be considered a medication error.

In a face-to-face interview on 07/13/10 at 8:35am, Director of Respiratory S40 could give no explanation for the number of missed respiratory treatments. She confirmed there were no medication variance reports submitted for the missed treatments.

Based on record review and interview, the hospital failed to meet the Condition of Participation for Medical Staff as evidenced by having approved medical staff bylaws that allowed respiratory care ordered by physicians to be prioritized for provision of services to patients which ultimately allowed ordered respiratory treatments to not be performed as ordered by physicians. The hospital developed and implemented a respiratory policy that allowed respiratory treatments to be triaged when the quantity of work exceeded respiratory therapy resources which resulted in 162 missed treatments involving 2 of 20 patients reviewed for respiratory treatment administration from a total of 34 sampled patients (#15, #26), 9 of 16 random patients reviewed for respiratory treatment administration from a total of 18 random patients (#R1, #R3, #R4, #R5, #R6, #R13, #R15, #R16, #R17), and 57 missed respiratory treatments identified from 04/01/10 through 04/15/10 and 06/01/10 through 06/15/10 (see findings cited at 0347).

Based on record review and interviews, the hospital failed to ensure: 1) the reappointment process for teleradiologists was performed according to the medical staff bylaws for 2 of 11 teleradiologists privileged by the hospital (S29, S30) and 2) the tuberculosis screening and assessment was conducted according to the medical staff bylaws for 1 of 14 physicians reviewed from a total of 265 appointed physicians (S34). Findings:

1) Reappointment of teleradiologists:
Review of Teleradiologist S29's credentialing file revealed he was appointed on 01/01/09. Further review revealed no documented evidence a reappointment application had been sent to S29 by 07/01/09 as required by the medical staff bylaws.

Review of Teleradiologist S30's credentialing file revealed he was appointed on 01/01/09. Further review revealed no documented evidence a reappointment application had been sent to S30 by 07/01/09 as required by the medical staff bylaws.

In a face-to-face interview on 07/08/10 at 1:20pm, S38, Manager of Medical Staff Services, indicated the teleradiology physicians were granted clinical privileges and were not medical staff members. She indicated they were expected to complete applications for reappointment. S38 confirmed Teleradiologists S29 and S30 had not had their reappointment applications sent to them as of the time of this interview, and the medical staff bylaws required the applications to be sent 6 months in advance of reappointment.

Review of the "Bylaws of the Medical and Dental Staff ", revised 12/10/09, revealed, in part, " ...The reapplication form is mailed to each practitioner scheduled for reappointment six months prior to expiration of the appointment period. ... Rules and Regulations for Telemedicine ... Qualified applicants may be granted telemedicine privileges, but they will not be appointed to the Medical Staff. Privileges will be granted for a period of not ore than 24 months. Applicants seeking to renew telemedicine privileges will be required to complete an application ... " .

2) Tuberculosis screening & (and) assessment:
Review of Physician S34's credentialing file revealed he was appointed 01/01/10 to the medical staff. Further review revealed S34 had a BCG (Bacille bilie' de Calmette-Guerin) vaccination in the past. Further review revealed no documented evidence of a chest x-ray or PPD (purified protein derivative) result as required by the medical staff bylaws.

In a face-to-face interview on 07/08/10 at 8:55am, Credentialing and Privileging Specialist S28 confirmed there was no chest x-ray or TB results in S34's credentialing file.

Review of the "Bylaws of the Medical and Dental Staff ", revised 12/10/09, revealed, in part, " ... Tuberculosis Screening & (and) Assessment ... Documentation of a screening & assessment for tuberculosis is a condition of appointment, reappointment and continued affiliation ... PPD or chest x-ray is required as baseline if BCG (Bacille bilie' de Calmette-Guerin) has been previously administered ... " .

Based on record review and interviews, the hospital failed to ensure the medical staff was accountable to the governing body for the quality of medical care provided to patients by failing to require respiratory treatments to be administered as ordered by the physician by having medical staff bylaws that allowed respiratory care to be prioritized based on operations and having a policy that allowed respiratory treatments to be triaged when the quantity of work exceeded resources which resulted in 162 missed respiratory treatments
involving 2 of 20 patients reviewed for respiratory treatment administration from a total of 34 sampled patients (#15, #26), 9 of 16 random patients reviewed for respiratory treatment administration from a total of 18 random patients (#R1, #R3, #R4, #R5, #R6, #R13, #R15, #R16, #R17), and 57 missed respiratory treatments identified from 04/01/10 through 04/15/10 and 06/01/10 through 06/15/10. Findings:

Review of patient medical records and the lists of missed treatments from 04/01/10 through 04/15/10 and 06/01/10 through 06/15/10, presented by Director of Respiratory S40 as the list of missed respiratory treatments, revealed a total of 157 missed respiratory treatments.

In a telephone interview on 07/13/10 at 9:10am, Medical Director of Respiratory Services S32 confirmed he was the Medical Director of Respiratory Services. He indicated he was not aware there had been 162 missed treatments. S32 confirmed he did not write the triage or prioritization policies, and he was not involved in the revision of the triage policy in 03/10. He indicated he could not answer any questions related to staffing of the respiratory department, as his role was to interpret pulmonary function tests, give advice in medical emergencies, answer questions about treatments/medications, suggest types of respirators to purchase, and suggest the type of spirometry to use. He further indicated he was not involved with the quality improvement of the respiratory department; he saw his role as that of a consultant. When questioned about the number of missed treatments, he confirmed he was not notified that treatments were being missed. He further indicated patients don't get their treatments as ordered at home, so they're at least getting more at the hospital than at home.

Review of the hospital policy titled "Respiratory Care Time Standards", last revised 03/09, revealed, in part, "...Services will be rendered as close to the time standards as possible, although the fact that a single RCP (respiratory care practitioner) is assigned as many as 10-12 patients makes it impossible to provide all treatments at the exact prescribed time. The therapist may stagger treatment times to keep the intervals between treatments appropriate. The general expectation is that treatments will be given within two hours before or after the targeted treatment time ... " .

Review of the "Bylaws for the Medical and Dental Staff", with a revision date of 12/10/2009, revealed, in part, "... Section 10 Rules and Regulations for the Respiratory Department ... 1. Prioritization Policy and Procedure A. Purpose: To assure that those patients most in need of therapy receive ordered treatments. B. Treatments should be allocated in the following manner when operational factors dictate that some bronchial hygiene procedures may be missed. The highest priority will be patients in Category #1 with priority decreasing in descending order. 1. a. Patients acutely short of breath or with acute airway obstruction. b. Patients requiring sputum induction prior to initiation of antibiotic therapy. 2. a. Patients chronically short of breath. b. Patients at high risk for developing atelectasis (especially those postop abdominal and thoracic patients with decreased sensorium). 3. Patients bringing up sputum. 4. Patients not meeting above criteria but with a bronchodilator ordered. 5. Routine postop patients (patients who have not has thoracic or abdominal surgery). 6. Patients not meeting above criteria who have normal saline nebulizers ordered. C. When treatments are missed due to prioritization, the Respiratory Care Practitioner will alert the relevant nursing and medical staff. D. Assignment of priority of therapy shall be performed by certified technicians and above. This Plan applies to bronchial hygiene procedures on the "floor" only. Other critical modalities (e.g., ventilator patents, newborn care, blood gases, pulmonary functions) are not subject to prioritization ...".

Review of the hospital policy titled "Medical Director, Respiratory Care Services", last revised 05/07 and presented as the hospital's current policy,revealed, in part, "... Policy Statements: 1. Medical direction is provided on a full time basis by a member of the Medical staff. The physician medical directed possess expertise in the management of patients with respiratory impairments ... 2. The Medical Director is responsible for the following: 2.1 Works directly with the RC (respiratory care) Department Director and leadership team in assuring that department policies, protocol and procedures are appropriate and adhered to b providing overall direction in the provision of services in the inpatient and clinic settings. 2.2 Assures that the quality, safety, and appropriateness of respiratory care services are monitored and evaluated and that appropriate actions based on findings are taken. 2.3 Is held accountable by the medical staff for the quality and appropriateness of respiratory services. 2.4 Is held accountable by the medical staff for the provision of technology needed to administer respiratory services. 2.5 Provides medical oversight and serves as a resource to identify performance improvement opportunities. 2.6 Provides/oversees training and in-services on a periodic basis to insure that the staff is current in pulmonary medicine and procedures. 2.7 Provides consultation/teaching to staff members. 2.8 Provides input to the Director relating to staffing, budget, capital equipment, personnel selection and staff performance ...".
Review of the hospital policy titled "Respiratory Care Service Triage of Resources", last revised 03/10, revealed, in part, "...The triage policy provides specific guidelines related to those periods which the quantity of work exceeds resources available. Such situations may occur in the event of acute increases in work demand, or in situations of acute staff shortages as a result of the inability of staff to report to work. 3. The triage procedure can be activated by the Charge Therapist. ... 1. Procedure The need to activate RC (respiratory care) triage should first be assessed. In the event an RCP (respiratory care practitioner) experiences acute increases in work demand and is unable to provide the requested and necessary care, they will contact the team leader to report the situation. The team leader will make an assessment of any other fluctuations in work demand and the ability to cross utilize RCP resources from other areas of the hospital. ... The following procedures can be deferred for a 24-hour period: Equipment change aerosol, Equipment change ventilator, Equipment change BiPAP/CPAP, Ballard cath change ... Treatment frequencies for chest physiotherapy maneuvers and supervised incentive spirometry can be changed from QID (4 times a day) to BID (2 times a day). Ventilator checks can be changed from Q3 hours (every 3 hours) to Q4 hours (every 4 hours) for patients that have been stable over the past 24 hours and are not requiring high levels of support... 2. Any interventions missed as a result of the triage task must be reported to the other primary care givers through the patients nurse. Such therapy omission will also be documented in Meditech with the reason not done. 3. If after the progressive implementation of the above measures the team leader or staff, do not have the necessary resources available the Director or Medical Director of the department will be contacted".

Based on review of medical records, policy and Medical Staff By-Laws staff interview the hospital failed to follow policy and procedure as evidenced by failing to have a completed H&P on a patient's medical record within 24 hours of admission for 2 of 34 sampled medical records (Patient #15, #23). Findings:

Patient #15
Review of the medical record revealed Patient #15 had been admitted to the hospital on 07/02/10 with the diagnosis of pneumonia possibly hospital acquired. Review of the H&P filed in the chart revealed no documented evidence it had been signed and dated by the physician as evidenced by a blank in the space provided for the physician's signature.

Patient #23
Review of the medical record revealed Patient #23 had been admitted to the hospital on 07/06/10 with the compliant of a bloody bowel movement. Review of the H&P filed in the chart revealed no documented evidence it had been signed and dated by the physician as evidenced by a blank in the space provided for the physician's signature.

Review of the Medical Staff By-Laws/Rules and Regulations, effective 07/07/09, revealed .... 9. History & Physical Examination: a. A complete medical history and physical examination shall in all cases be recorded on the patient's chart and signed, dated and timed within 24 hours following admission of the patient " .

In a face to face interview on 07/07/10 at 3:34pm Physician S13 Vice President of the Medical Staff indicated the hospital had been working with the medical staff in correcting some of the identified problems within the medical records. Further he indicated on-line signing would be added sometime in the future since all of this information would be computerized.

Based on record reviews and interviews, the hospital failed to ensure the registered nurse (RN) supervised and evaluated each patient's care by failing to: 1) notify the physician of a change in a patient's blood pressure for (#9); 2) complete an admit assessment on a patient before sending the patient to surgery (#13) for 5 of 5 medical records reviewed for patients going to surgery; 3) perform accurate skin assessments on admit and every shift according to policy and procedure resulting in 2 patients having pressures ulcers discovered 2 days after admit (#34 and random patient R9) for 2 of 3 medical records for patients with pressure ulcers; and 4) monitor consults to ensure they are done as ordered by the physician (#1, #13, #23) for 3 of 34 sampled medical records and 1 random medical record. Findings:

1) notify the physician of a change in a patient's blood pressure
Review of the medical record for Patient #9 revealed she was admitted to the hospital on 7/6/10 with the diagnosis of bilateral hydronephrosis. Further review revealed #9 was discharged from PACU at 2:00pm (1400), admitted to Day Surgery Unit (DSU) from 2:05pm )1405) to 5:55pm (1755) and tranferred to Unit 31 (U31-the inpatient postoperative unit) at 7:20pm (1920).

Review of the nurses documentation dated, 7/6/10 revealed #9 was discharged from PACU at 2:00pm with a blood pressure reading of 166/62 (166 systolic over 62 diastolic) and admitted to DSU at 2:05pm with a blood pressure of 151/65 at 2:10pm (1410). Further review revealed #9's blood pressure ranged from the mid 140's systolic and mid low to high 60's diastolic from 2:25pm (1425) to 5:55pm (1755) in the DSU.

Further review revealed #9 was transferred from DSU at 7:20pm with a blood pressure of 156/69 to Unit 31 (U31) at 7:35pm. Review of the nurses documentation dated/timed, 7/6/10 at 7:35pm read, "Pt arrived to room from surgery ... Denies Pain ... " . There was no documented evidence for 30 minutes of what #9's blood pressure was when admitted onto U31.

Review of the "Frequent Vital Signs Check Sheet" for U31 revealed #9's blood pressure was: 184/68 at 7:50pm (1950) -30 minutes after admitted on the unit, 202/82 at 8:05pm (2005), 179/125 at 8:20pm (2020), and 169/52 at 8:35pm (2035).

Further review revealed #9's systolic pressures of 184 (at 7:50pm) was 28 points above the baseline reading, 202 (8:05pm) was 46 points above the baseline reading, and 179 (8:20pm) was 23 points above the baseline reading of 156 at 7:20pm. #9's diastolic blood pressure of 125 (at 8:20pm) was 56 points above the baseline reading of 69 at 7:20pm. There were no documented evidence #9's systolic and/or diastolic readings of 20 points above baseline reading of 156/69 were reported to the attending physician on 7/6/10.

In a face-to-face interview on 7/7/10 at 1:40pm, S44U31, Director verified #9's baseline blood pressure was 156/69 with 156 systolic and 69 diastolic. S44 confirmed #9 had blood pressures of 184/68 (7:50pm), 202/82 (8:05pm), and 179/125 (8:20pm). She stated the normal blood pressure ranges are 120 systolic and 80 diastolic. She indicated all blood pressure readings greater than 120 systolic and 80 diastolic are abnormal readings that should be reported to the attending physician. She further indicated #9's abnormal blood pressure readings of 184/68 (7:50pm), 202/82 (8:05pm), and 179/125 (8:20) should had been reported to the attending physician. She verified there was no documented evidence in #9's record that the registered nurse reported the abnormal systolic and/or diastolic blood pressure readings to the attending physician on 7/6/10. She indicated the abnormal systolic and diastolic blood pressures for #9 were a change in the patient's condition. She reported the nurse reports the abnormal blood pressure readings and a change in the patient's condition to the attending physician within the hour. She indicated the nurse did not follow the policy to notify the physician of #9's abnormal blood pressures or change in the patient's blood pressure on 7/6/10.

A face-to-face interview on 7/9/10 at 9:10am was held with S8DON (Director of Nursing). She reviewed #9's medical record for 7/6/10. She verified #9' s baseline blood pressure readings were 156/69 at 7:20pm. She indicated #9's baseline blood pressure was 156 systolic and 69 diastolic at 7:20pm. She confirmed #9's systolic pressures were 20 points above the baseline reading of 156 at 7:20pm. She verified #9's diastolic blood pressure was 56 points above the baseline reading of 69 at 7:20pm. She indicated #9's systolic pressures of 184, 202, and 179 and diastolic pressure of 125 were changes in the patient's (#9's) condition that should had been reported to the attending physician on 7/6/10. She verified there was no documented the attending physician was notified of #9's change in blood pressure on 7/6/10. She indicated the nurse did not follow the hospital's policy to report a patient's blood pressure of 20 points above the baseline reading to the physician. She further indicated the nurse did not follow the policy to notify the attending physician of a change in the pateint's condition (blood pressure) within one hour.

Review of the policy titled "Vital Signs", Procedure Number: NR-1-2-40, page 2 of 2, Reviewed/Approved: 3/94, 5/97, 09/97, 12/99, 12/01, 7/03, 12/05, 7/08, 9/08, 6/10, presented as the hospital's current "Vital Sign" policy on 7/8/10 at 5:20pm revealed, in part, "...Procedure-...III. Check B/P (blood pressure)... Report abnormalities "+" or "-" 20 points baseline...".

Review of the policy titled "Vital Signs", Procedure Number: NR-1-2-40, page 2 of 3, Reviewed/Approved: 3/94, 5/97, 09/97, 12/99, 12/01, 7/03, 12/05, 7/08, 9/08, presented as the hospital's current "Vital Sign" policy on 7/9/10 at 11:30am revealed, in part, "...III. Check B/P. Report abnormalities above 140 systolic or above 90 diastolic...".

2) RN completed an admit assessment on a patient before going to surgery
Review of the medical record for Patient #13 revealed he had been admitted to the hospital on the morning of 07/06/10 for a Femoral Popliteal Bypass surgery. Review of the nursing documentation revealed no documented evidence an initial assessment had been performed on Patient #13 before surgery.

In face to face interview on 07/07/10 at 10:35am RN S22 verified she had obtained admit data, but had not perfomed a complete admit assessment on Patient #13.

In a face to face interview on 07/07/10 at 10:45am RN 18 Risk Assessment Director indicated the hospital policy states an admit assessment is performed on all patients at the time of admit.

3) perform accurate skin assessments on admit and every shift according to policy and procedure
Patient #34
Review of the medical record for Patient #34 revealed she had been admitted to the Geri-Psych Unit of the hospital on 01/28/10 from a nursing home facility with the diagnoses of dementia, agitation, depression and a broken nose from a fall at the nursing home. Further S34 had a reported history of bi-polar disorder and failure to thrive.

Review of the Admission Nursing Assessment dated 01/28/10 revealed no documented evidence Patient #34 had a pressure ulcer upon admit. Review of the daily skin assessments for Patient #34 revealed on 02/07/10 a skin assessment was performed an a Stage II decubitus ulcer to the coccyx was identified, a wound care ulcer ordered and treatment initiated.

Review of the Physician ' s Progress dated/timed 02/08/10 at 1715 (5:15pm) revealed, " Stage II wound on coccyx not documented on admit assessment but looks old " .

Random Patient R9
Review of the medical record for Random Patient R9 revealed she had been admitted to the Geri-Psych Unit of the hospital on 03/17/10 from a nursing home facility were severe dementia, agitation and increased confusion. Further she had sustained a fall approximately three weeks ago causing a fracture to the left ankle which was repaired with an open reduction internal fixation.

Review of the H&P (History & Physical) dated 03/19/10 revealed under "Extremities" The left ankle is wrapped and in a cast." There was no documented evidence any abnormalities of the skin around the cast on the left leg had been identified.

Review of the Psychiatric Evaluation Data Collection form dated 03/17/10, Patient R9's left foot in soft bandage due to a pre-admit fall and surgery.

Review of the Initial Nursing Assessment for R9 dated 03/17/10 revealed in the Musculoskeletal Comment that she had a cast to her left leg from a fall that she had 2 weeks ago and broke her ankle; Site dressing dry and intact; and the skin assessment had no documented evidence of any redness to the left leg or that a pin from the internal fixator was protruding from the heel.

Review of the Physician's Orders for R9 dated 03/18/10 at 1:30pm revealed an order to consult the wound care consult.

Review of the Inpatient Progress Notes for Wound Care dated 03/19/10 at 10:20 indicated R9 had a 0.9 x 0.9 x 0.1cm pressure ulcer to her left lower leg @ proximal medical aspect and a 2 x cm maceration to her left heel where the pin is visible.

In a face to face interview on 07/13/10 at 9:15am S16 Director of the Psychiatric Unit indicated the incidents of pressure ulcers occurred in the earlier part of the year and she has been working hard with her staff to educate them on the total care of the patient. Further S16 indicated she emphasized the importance of initial assessments and had counseled the nurses involved in not performing accurate assessments.


4) monitor consults to ensure they are done as ordered by the physician (#1, #13, #23);
Patient #1
Review of the medical record for Patient #1 revealed he had been admitted to the hospital on 07/03/10 with a pulmonary embolus. Review of the Physician's Orders dated/timed 7/03/10 (no time documented) revealed an order for a consult with the Oncology/Hematology service and again on 07/06/10 (no time documented) to make sure Oncology/Hematology was aware of the consult. Review of the consult form dated 07/04/10 at 8:15am revealed a message was left with the answering service for the Oncology/Hematology Service concerning the consult; however there is no documented evidence in the chart of a return call from the physician as to when he/she would see the patient and the consult form remained with no documented evidence a consult had been performed by the Oncology/Hematology physician as of 07/07/10.

In a face to face interview on 07/07/10 at 10:10am RN 18 verified the consult had not been performed. Further she indicated the hospital does not have a system of tracking consults to ensure they have been done.

Patient #13
Review of the medical record for Patient #13 revealed he had been admitted to the hospital on 07/06/10 at 0600 (6:0am) for surgery (Femoral Popliteal Bypass). Review of the Physician's Orders dated/timed 07/06/10 at 0600 (6:00am) revealed an order for a cardiology consult. Further review of the medical record revealed no documented evidence the physician had been notified of the consult. Review of the Post-op orders for Patient #13 dated/timed 07/06/10 at 9:25am revealed an order to notify Cardiology "please".

In a face to face interview on 07/07/10 at 1:30pm RN S18 indicated there was no evidence that the cardiology had been notified he had a consult and the patient was taken to surgery before it was done.

In a face to face interview on 07/08/10 at 4:50pm RN S12 Director of Quality Management indicated consults are put in the Meditech system (computer system) and that is how the physicians see the consults and the staff calls the office.

Patient #23
Review of the medical record revealed Patient #23 was admitted to the hospital on 07/07/10 for a GI (Gastrointestinal) Bleed. Review of the Physician's Admit Orders dated/timed 07/07/10 at 0329 (3:29am) revealed an order to consult Gastroenterology Service. Review of the Physician ' s Orders dated 07/08/10 (no time documented) revealed, "Please call GI today."

In a face to face interview on 07/08/10 at 10:50am RN S36 Director of Medical Telemetry indicated there was no evidence the transcribing clerk had documented that a call had been place to the GI service for notification of a consult on 07/07/10 when initially ordered by the physician. Further she indicated according to the computer, the consult was put in on 07/07/10 at 0422 (4:22am).

Based on record reviews and interview, the hospital failed to: 1) ensure the nursing staff followed the plan of care for each patient by failing to administer blood products as ordered by the physician for 1 of 2 patients reviewed for blood administration (#27); 2) ensure the nursing staff developed interventions and measurable goals for a patient with pulmonary emboli (#1); and 3) ensure nursing staff develop a nursing care plan upon admit (#13) for 3 from a total of 34 sampled patients. Findings:

1) ensure the nursing staff followed the plan of care for each patient by failing to administer blood products as ordered by the physician
Review of Patient #27's medical record revealed he was admitted into the hospital for an upper gastrointestinal bleed, severe anemia and other medical diagnosis on 1/17/10. Further review revealed a "Physician Order Sheet" written, 1/17/10 2:15am (0215) to "...Transfuse 2 u (units) PRBCs (packed red blood cells), Each over 2h (two hours) IV (intravenous)...".

Review of the "Blood Bank Issue Tranfuse Records" for 1/17/10 revealed #27 received two (2) units of PRBCs. His first unit of blood started at 4:10am (0410) and completed at 5:20am (0520). His second unit of blood started at 6:00am (0600) and completed at 7:10am (0710). The 2 units of PRBCs were both infused to #27 in one (1) hour and ten (10) minutes.

In a face-to-face interview on 7/8/10 at 2:50pm, S8 DON (Director of Nursing) verified the physician's order to infuse the 2 units of PRBCs each over 2 hours was not followed by the nurse for Patient #27. She indicated the physician's order was not followed to administer the 2 units of blood products over 2 hours. She further indicated the nurse did not follow the blood product policy to verify the physician's order.

Review of the hospital policy titled, "Blood Transfusion Procedure", revised/approved dates: 10/90, 3/91, 6/97, 10/97, 2/00, 12/02, 8/03, 5/06, 9/08, 1/2010, 6/10, presented as the hospital's current "Blood Transfusion" policy on 7/9/10 at 11:30am read, "... Procedure- I. Verify physician's order...".

2) ensure the nursing staff developed interventions and measurable goals for a patient with pulmonary emboli
Review of the medical record revealed was a 39 year old male who had been admitted to the hospital on 07/03/10 with a pulmonary embolus. Further review revealed he was a college graduate and according to the initial nursing assessment dated 0703/10 had not been assessed with any learning or communication problems. Review of the Care Plan revealed the following identified problems and daily assessment of progress: Patient will demonstrate improved comprehension 07/04/10, 07/05/10, 07/06/10 - documented "progressing"; Patient will maintain circulation 07/04/10, 07/05/10, 07/06/10 - documented "progressing"; and Patient will exhibit compliant behavior 07/04/10, 07/05/10, 07/06/10 - documented " progressing". Further review of the care plan revealed no documented evidence of the interventions to be used or measurable goals.

In a face to face interview on 07/07/10 at 11:00am staff nurse RN S23 indicated the care plans used in the hospital are not specific.

3) ensure nursing staff develop a nursing care plan upon admit
Review of the medical record for Patient #13 revealed he had been admitted to the hospital on the morning of 07/06/10 for a Femoral Popliteal Bypass surgery. Further review of the medical record revealed no documented evidence a plan of care had been initiated upon admit.

Review of policy number TX-A-450, last revised/approved 03/10 and submitted as the one currently in use revealed the plan of care would be developed through "collaboration with other disciplines" and initiated by the RN. According to the policy the plan of care is built in the Meditech system (computerized charting) related to the needs identified at the time of the admit assessment, expected outcome identified and interventions and actions to be taken. Further review of the policy revealed the plan of care utilized by the hospital does not include measurable outcomes.

Based on review of medical records and staff interview the hospital failed to ensure medications had been administered according to physician orders as evidenced by failure to administer a now order of Warfarin (anticoagulant) for Patient #1 with a diagnosis of a pulmonary embolus and failure to administer Levaquin (antibiotic) as ordered for a total of three missed dosed for Patient #15 with a diagnosis of pneumonia for 2 of 34 sampled medical records with a potential to effect all patients receiving medication administration. Findings:

Patient #1
Review of the medical record for Patient #1 revealed he was admitted to the hospital on 07/03/10 with the diagnosis of a possible pulmonary embolus and pneumonia. Review of the Physician's Orders dated 07/03/10 (no time documented) for Patient #1 revealed ..... " Warfarin 5 (FIVE) mg i po (by mouth) now X 1 (one time) than i po Q (every) 5PM starting tomorrow " .

Review of the MAR (Medication Administration Record) for Patient #1 revealed no documented evidence Warfarin had been administered on 07/03/10 at 5PM as a "one time now" order. Further review revealed Warfarin was administered to Patient #1 as follows: 07/04/10 and 07/05/10 at 1400 (2:00pm) every day instead of at 5:00pm as ordered by the physician.

In a face to face interview on 07/07/10 at 10:00am RN S19 indicated Warfarin is usually scheduled by the pharmacy to be given every day at 2:00pm unless the physician orders a specific time. S19 indicated when the physician writes for a specific time, it should be clarifies with the pharmacy.

In a face to face interview on 07/07/10 at 10:05am Pharmacist S20 indicated if the physician doesn ' t order a time for Warfarin (Coumadin) the pharmacy uses 2:00pm. Further S20 indicated she could not explain why the physician ' s ordered time for Patient #1 had not been used.

In a face to face interview on 07/07/10 at 10:10am S21 Director of Pharmacy indicated the pharmacy taking the orders off for the Warfarin (Coumadin) for Patient #1 didn ' t note the time the medication was ordered to be given so the computer automatically defaulted to 2:00pm.


Patient #15
Review of the medical record revealed Patient #15 was admitted to the hospital on 07/02/10 with the diagnosis of pneumonia possibly hospital acquired. Review of the Physician's Admit Orders dated 07/02/10 at 2005 (8:05pm) revealed an order for Levofloxacin 750mg IV (Intravenous) every 24 hours.

Review of the faxed Pneumonia Admission Order set for Patient #15 faxed to the pharmacy department from Unit 43 on 07/02/10 at 08:07:53PM revealed no documented order for Levofloxacin 750mg IV (Intravenous) every 24 hours.

Review of the MAR (Medication Administration Record) dated 07/02/10 through 07/05/10 for Patient #15 revealed no documented evidence the Levofloxacin 750mg IV (Intravenous) every 24 hours had been administered as ordered.

In a face to face interview on 07/07/10 at 3:00pm S36 Clinical Pharmacist indicated Levofloxacin 750mg IV (Intravenous) every 24 hours had not been checked off to be given when the orders had been faxed to the pharmacy on 07/07/10. Further S36 indicated she noticed the discrepancy when she reviewed Patient #15's chart on 07/06/10 and it was not on the profile of the active medication list.

Based on review of medical records, Medical Staff Rules and Regulation, and interview the hospital failed to follow their policy and procedure for dating, timing and signing of all entries by: 1) failing to ensure all progress notes were dated and or timed for 2 of 34 sampled medical records (#4, #24) for 2 of 34 sampled medical records. Findings:

1) failing to ensure all progress notes were dated and or timed
Patient #4
Review of the medical record for Patient #4 revealed Progress Notes dated 06/26/10, 06/27/10, 07/04/10 and 07/05/10 were not timed. This was confirmed by S42, Assistant Administrator of Operations.

Patient #24
Review of the Progress Note for Patient #24 dated 07/06/10 revealed no documented time the entry had been made by the physician into the medical record. Review of the Hospitalist Assessment form for Patient #24 dated 07/07/10 revealed no documented evidence the time the assessment had been performed as evidenced by a blank in the space provided for the time.

Review of the Medical Staff By-Laws and Rules and Regulations, effective 07/07/09, revealed in the General Rules and Regulations that physician Progress Notes should be "legible, signed, dated, and timed by the responsible Medical Staff member."

Based on record review (patient medical records, Medical Staff Bylaws) and interviews, the hospital failed to ensure all orders, including verbal orders, were timed, dated, and authenticated by the ordering physician and the receiver of the verbal order included a read-back verification for 5 of 34 sampled patients (Patients #1, #4, #13, #15, #24. Findings:

Patient #1
Review of the Physician's Orders for Patient #1 revealed no documented time the following orders had been written by the physician: 07/06/10 for a request for a Radiology report; 07/06/10 for lab work, Chest x-ray, Consult, and Benadryl for sleep; 07/04/10 labs, Echo, Respiratory Treatments and medication; 07/04/10 medication order; and 07/03/10 for medication, consults and lab work.

Patient #4
Record review for Patient #4 revealed Anesthesia Post Operative Verbal Orders dated 06/22/10 9:40am with no documented evidence of the read-back verification by the nurse receiving the order. Further review revealed "Doctor's Orders" dated 06/26/10, 06/27/10, 06/28/10, 06/30/10, 07/01/10 and 07/02/10 were not timed. This was confirmed by S42, Assistant Administrator of Operations.

Patient #13
Review of the Physician's Orders for Patient #13 revealed no documented time an order had been written by the physician on 07/06 (no year documented) for blood pressure parameters.

Patient #15
Review of the Physician's Orders for Patient #15 revealed no documented time the following orders had been written by the physician: 07/02/10 for medication and 07/02/10 for a respiratory treatment.

Patient #24
Review of the medical record for Patient #24 revealed he had been admitted to the hospital on 07/06/10 with the diagnoses of colitis, UTI (Urinary Tract Infection), abdominal pain and renal insufficiency with a history of DM (Diabetes Mellitus). Review of the following orders revealed no documented evidence the verbal orders had been readback: 07/06/8:10pm order clarification for Tramadol and Trazadone; 07/06/10@2226 (10:26pm) for Sliding Scale Insulin; 07/06/10 @ 2226 (10:26pm) Tylenol for temperature; and 07/06/10 @ 2255 (10:55pm) for Foley catheter.

Review of the Medical Staff Bylaws, with a revision date of 12/10/2009 revealed, in part, "... Medical Record b. Content 1. All others for treatment shall be in writing and recorded with date and time in the medical record." Review of the policy entitled Read Back Process for Verbal and Telephone Orders and Critical Values" policy #TX-B-020, presented as the hospitals current policy revealed in part, "IV, Process 1. All verbal/telephone orders will be taken and transcribed in the designated section of the patient's medical record. 4. The order is then verbally read back to the Provider as written on the medical record. 5. Once the Provider confirms the order, VR. for verbal read back is written after the signature. 6. The order may then be carried out." Review of the rules and regulations for Pharmacy and Therapeutics revealed in part, "a. Date and time with signature must accompany all orders."

Based on observation, record review, and interview the hospital failed to ensure drugs were administered according to acceptable professional principes as evidenced by:

1) failed to ensure drugs were properly identified and labeled

Observation of the medication room on the Rehabilitation unit on 07/07/10 at 11:20 am revealed a 1/2 pill in a medicine cup which was not labeled identifying the medication,dose of the medication or patient name who was receiving the medication. This was confirmed by S24, RN. She indicated she could not identify the medication and she would discard it.

Review of the Louisiana Administrative Code Title 46 Part LIII: Pharmacists Chapter 15. Hospital Pharmacists revealed in part, "1513. Labeling A. all drugs dispensed by a hospital pharmacy,intended for use within the facility, shall be dispensed in appropriate containers and adequately labeled as to identify patient name and location, drug name(s) and strength, and medication dose(s)."

Based on observation, record review, and interviews, the hospital failed to follow its policies and procedures for reporting of medication variances by failing to initiate a medication variance report for 162 identified respiratory medication variances involving 2 of 20 patients reviewed for respiratory treatment administration from a total of 34 sampled patients (#15, #26), 9 of 16 random patients reviewed for respiratory treatment administration from a total of 18 random patients (#R1, #R3, #R4, #R5, #R6, #R13, #R15, #R16, #R17), and 57 missed respiratory treatments identified from 04/01/10 through 04/15/10 and 06/01/10 through 06/15/10. Findings:

Patient #15
Observation on 07/08/10 at 3:20pm revealed Respiratory Therapist (RT) S45 did not administer the scheduled respiratory treatment for Patient #15, who was a patient in ICU (intensive care unit).
In a face-to-face interview on 07/08/10 at 3:20pm, RT S45 indicated she was the only RT in ICU at the time, and they were short-staffed. She further indicated she had patients on ventilators, she had just finished extubating a patient, and Patient #15 was not triaged as a critical patient.

Patient #26
Review of Patient #26's physician orders for the admission of 06/17/10 revealed the following orders:
06/18/10 at 8:15am - Albuterol 2.5 mg (milligrams) and Atrovent 0.5 mg per nebulizer every 6 hours and prn (as needed), with no documented evidence of the symptoms that would require the prn dosage;
06/19/10 - Xopenex 0.63 mg QID (4 times a day) and prn SOB (shortness of breath) and Pulmozyme 2.5 mg BID (twice a day) and prn SOB.
Review of the "Edit MAR" (medication administration record) revealed the Atrovent was administered on 06/18/10 at 1533 (3:33pm) and at 1924 (7:24pm), less than 4 hours between administration when the order was for every 6 hours. Further review revealed the Albuterol was administered on 06/19/10 at 8:00am and 1314 (1:14pm), less than 6 hours between administration.
Review of the "Edit MAR" revealed Xopenex was scheduled for 8:00pm on 06/23/10 and was administered on 06/24/10 at 2:03am, which was more than 6 hours late. Further review revealed the scheduled 7:00am dose of Xopenex on 06/24/10 was administered at 9:39am, more than 2 ? hours late. Further review revealed the 8:00pm scheduled dose on 06/26/10 was administered at 5:10am on 06/27/10, more than 9 hours late; the 7:00am dose for 06/27/10 was administered at 6:38am, only 1 hour 28 minutes after the previously scheduled dose.
Review of the "Edit MAR" revealed Pulmozyme was administered on 06/20/10 at 6:56am and 7:21am with no documented evidence of the reason for the second administration.
Review of Patient #26's physician's orders for the admission of 06/30/10 revealed the following orders:
06/30/10 at 1645 (4:45pm) - Xopenex 0.63 mg/3 ml (milliliters) QID per neb (nebulizer) & (and) prn; Atrovent 0.5 mg/2.5 ml QID per neb;
07/01/10 at 1455 (2:55pm) Therapeutic Interchange by pharmacist for Albuterol 2.5 mg to substituted for Xopenex 0.63 mg.
Review of the MARs for Patient #26 revealed Albuterol and Atrovent were not administered on 07/02/10 at 11:00am and 07/03/10 at 7:00am due to "triage".

Patient R1
Review of Patient R1's physician orders on 07/07/10 at 1700 (5:00pm) revealed an order for Aerosol with Duonebs QID.
Review of Patient R1's MAR revealed no documented evidence Albuterol 2.5 mg and Atrovent 0.5 mg were administered on 07/08/10 at 4:00pm and on 07/09/10 at 11:00am.

Patient R3
Review of Patient R3's physician orders revealed an order on 07/01/10 at 2014 (8:14pm) for Neb tx (treatment) Atrovent/Proventil every 4 hours prn SOB.
Review of the MARs for Patient R3 revealed no documented evidence Atrovent and Proventil were administered as ordered on 07/02/10 at 12:00am, 07/02/10 at 12:00pm, 07/03/10 at 12:00am, 07/03/10 at 4:00am, 07/03/10 at 12:00pm, 07/04/10 at 4:00am, and 07/05/10 at 8:00am.

Patient R4
Review of Patient R4's physician orders revealed an order on 06/24/10, with no documented evidence of the time the order was written, for Albuterol 0.083% (per cent) - 3 cc (cubic centimeters) per nebulizer QID.
Review of Patient R4's MARs revealed no documented evidence Albuterol was administered on 06/26/10 at 11:00am; 06/27/10 at 4:00pm; 06/28/10 at 7:00am, 11:00am, 4:00pm, and 8:00pm; 06/29/10 at 7:00am, 11:00am, 4:00pm, and 8:00pm; 06/30/10 at 4:00pm; 07/01/10 at 11:00am; 07/02/10 at 7:00am, 11:00am, and 4:00pm; and 07/03/10 at 4:00pm.

Patient R5
Review of Patient R5's physician orders revealed an order on 07/06/10 at 2:05pm for Albuterol 2.5 mg/Atrovent 0.5 mg now and every 4 hours.
Review of Patient R5's MARs revealed no documented evidence Atrovent was administered as ordered on 07/06/10 at 1419 (2:19pm), )7/06/10 at 4:00pm, and 07/07/10 at 4:00am, 12:00pm, and 4:00pm. Further review revealed no documented evidence Albuterol was administered as ordered on 07/06/10 at 2:19pm and 4:00pm, on 07/07/10 at 4:00am and 4:00pm, 07/10/10 at 4:00am, and 07/11/10 at 4:00am.

Patient R6
Review of Patient R6's physician orders revealed an order on 06/30/10 at 10:50am for Xopenex 1.25mg/Atrovent 0.5 mg neb QID.
Review of Patient R6's MARs revealed no documented evidence Xopenex was administered for 2 treatments on 06/30/10, 2 treatments on 07/01/10, 4 treatments on 07/02/10, and 4 treatments on 07/03/10. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:30pm. Further review revealed no documented evidence Xopenex was administered as ordered on 07/04/10 at 4:00pm, 07/07/10 at 12:00am and 8:00am, 07/09/10 at 12:00am, and 07/10/10 at 12:00am.

In a face-to-face interview on 07/12/10 at 3:25pm, Information Technology Registered Nurse S27 confirmed the above findings.

Patient R13
Review of Patient R13's physician orders revealed an order on 06/21/10 at 2:35am for Neb txs 0.5 mg Atrovent and 2.5 mg Albuterol every 4 hours starting at 8:00am.
Review of the MARs for Patient #R13 revealed no documented evidence Atrovent was administered as ordered on 06/24/10 at 4:00pm; 06/26/10 at 8:00am, 12:00pm, and 10:00pm; 06/28/10 at 12:00pm and 8:00pm; 06/29/10 at 12:00am, 8:00am, and 12:00pm; 06/30/10 at 12:00am; 07/01/10 at 4:00am; 07/02/10 at 4:00am and 12:00pm; 07/04/10 at 12:00pm; 07/05/10 at 8:00am; 07/06/10 at 12:00am; and 07/07/10 at 4:00am. Further review revealed no documented evidence Albuterol was administered as ordered on 06/24/10 at 4:00pm; 06/26/10 at 8:00am, 12:00pm, and 8:00pm; 06/28/10 at 8:00pm; 06/29/10 at 12:00am, 8:00am, and 12:00pm; 06/30/10 at 12:00am; 07/01/10 at 4:00am; 07/02/10 at 4:00am and 12:00pm; 07/04/10 at 12:00pm; 07/05/10 at 8:00am; 07/06/10 at 12:00am; and 07/07/10 at 4:00am. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:25pm.

Patient R15
Review of Patient R15's physician orders revealed an order on 07/04/10 for Albuterol 2.5 mg/Atrovent 0.5 mg QID & prn.
Review of Patient R15's MARs revealed no documented evidence Albuterol was administered as ordered on 07/05/10 at 11:00am and 2217 (10:17pm). Further review revealed no documented evidence Atrovent was administered as ordered on 07/05/10 at 11:00am. These findings were confirmed by Director of Respiratory S40 on 07/12/10 at 4:45pm.

Patient R16
Review of Patient #R16's physician orders revealed an order on 06/18/10 at 6:05am for Albuterol 2.5 mg every 4 hours. Review of the MAR revealed it was not administered for greater than 4 hours after it was ordered. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:05pm.

Patient R17
Review of Patient R17's physician orders revealed an order on 06/18/10 at 11:07am for Albuterol neb 2.5 mg now x (times) 3 doses. Review of the MAR revealed no documented evidence of the final dose being administered. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:05pm.

Review of the list of "missed treatment from 04/01/10 through 04/15/10", presented by Director of Respiratory S40 as the list of respiratory treatments missed for this period of time, revealed a total of 34 missed treatments.

Review of the list of "missed treatment from 06/01/10 through 06/15/10", presented by Director of Respiratory S40 as the list of respiratory treatments missed for this period of time, revealed a total of 23 missed treatments.

No medication variance reports were presented by the hospital for the above respiratory medication variances.

In a face-to-face interview on 07/09/10 at 9:05am, Director of Respiratory S40 indicated an occurrence report (medication variance) is not completed by staff if a respiratory treatment is missed. She further indicated if a respiratory treatment is given late, greater than 2 hours from the ordered time, an occurrence report is completed, because that would be considered a medication error.

In a face-to-face interview on 07/13/10 at 8:35am, Director of Respiratory S40 could give no explanation for the number of missed respiratory treatments. She confirmed there were no medication variance reports submitted for the missed treatments.

In a telephone interview on 07/13/10 at 9:10am, Medical Director of Respiratory Services S32 indicated he was not aware there had been 162 missed visits. S32 confirmed he did not write the triage or prioritization policies, and he was not involved in the revision of the triage policy in 03/10. He indicated that he would expect the physician to be notified if more than 2 respiratory treatments per day were missed. S32 indicated he was not involved with the quality improvement of the respiratory department; he saw his role as that of a consultant. When asked by the surveyor what he considered a medication error for respiratory treatment, S32 indicated it would be a treatment missed greater than 2 times a day, a wrong dose of medication, or a wrong medication. He further indicated patients don't get their treatments as ordered at home, so they're at least getting more at the hospital than at home.

In a face-to-face interview on 07/13/10 at 9:35am, Director of Pharmacy S21 indicated pharmacy tracked and looked at respiratory treatments as a drug utilization review. She further indicated they looked at Xopenex and Albuterol in late Aril and early May 2010. When asked a second time about the review performed, S21 confirmed that what she had identified was treatments missed due to the patient being unavailable and not due to no reason given by the RT or for being triaged. When asked what she considered a medication error, S21 indicated she would look for a trend of the treatment being given outside the 2 hour window allowed for administration, and an error would be if no reason was documented for missing the treatment. She further indicated she would not consider a triaged respiratory treatment as a medication error. In a later interview on the same day at 10:50am, S21 confirmed the audit performed by pharmacy in April 2010 did not focus on missed treatments.

In a face-to-face interview on 07/13/10 at 1:00pm, Director of Respiratory S40 indicated the RT (respiratory therapist) triages the patient, that is, if the RT was busy with a code or critical patient, the other patient ' s scheduled treatment would be missed because of triaging. She further indicated the RT should be reporting any triaged treatment to the nurse, but she couldn't be sure that this report was documented each time. S40 indicated she is notified as the director of the unit, but the Medical Director is not notified. She confirmed that the RTs were not completing medication variances for triaged missed treatments. After reviewing the medication error policy as requested by the surveyor, S40 confirmed that the RTs were not following hospital policy for missed respiratory treatments.

In a face-to-face interview on 07/13/10 at 1:25pm, Director of Nursing S8 indicated the respiratory therapists were telling the nurses when treatments were missed, but that the majority of the time the nurses were not calling the physician when respiratory treatments were missed. She further indicated she was not aware until the present time of this interview that the hospital policy required the nurse to notify the physician when respiratory treatments were missed.

Review of the hospital policy titled "Respiratory Care Time Standards", last revised 03/09, revealed, in part, "...Services will be rendered as close to the time standards as possible, although the fact that a single RCP (respiratory care practitioner) is assigned as many as 10-12 patients makes it impossible to provide all treatments at the exact prescribed time. The therapist may stagger treatment times to keep the intervals between treatments appropriate. The general expectation is that treatments will be given within two hours before or after the targeted treatment time ...".

Review of the hospital policy titled "Respiratory Care Service Medication Errors", last revised 03/10, revealed in part, "... A medication error reporting program is mandated by JCAHO (Joint Commission Accreditation of Health Care Organizations) and is a function that all RCPs (respiratory care practitioners) administering medications is held accountable. By reporting errors, changes can be made in treatment to minimize the potential for adverse response and identify opportunities for improvement. Reporting is a voluntary and accomplished through both the Med-error form and delivered to risk management. Definition: A medication error is defined as any preventable medication related event that may lead to inappropriate use or cause patient harm. Such events may be related to professional practice, procedures, or systems. The medication use process includes prescribing, order communication, dispensing, distribution, administration, patient education and monitoring response. The RCP (Respiratory Care Practitioner) may observe an error or omission in any of the process identified. Policy Statement: 1. The medication error policy for RC incorporates the identification and reporting of events that include: a. Adverse response to aerosolized medications (as detailed in the policies for aerosol medications) b. Errors in type, dose, or timing of administration c. Missed therapies i. PRN treatments are excluded from missed therapy counts ii. A therapy is considered missed if the RCP is not able to perform it by the end of the shift in which it is due. (Ex: If a treatment is scheduled to be given every 4 hours, but the next treatment is not given until 8 hours later it would be considered a missed treatment). 2. The RCP will document all medication errors in meditech. 3. Meditech provides for the entry of any treatment not started and the capture of the reason why. Meditech provides for the entry of adverse response and the capture of the observation. a. As per hospital policy, for any medication that is not given or late, the RCP must also complete a medication error form and report it to the RC Director".
Review of the hospital policy titled "Medication Errors (Medication System Failures)", last revised 01/09, revealed, in part, "Policy The Department of Pharmacy Services shall establish and participate in a multidisciplinary quality improvement program that documents and assesses medication system failures. ... Medication errors are failures in the medication use system that allow patients to be exposed to drug therapies that have mistakes in prescribing, dispensing, administration, and patient compliance. ...Types of medication errors include: ... Omission Error - The failure to administer an ordered dose to a patient before the next scheduled dose. Excluded are (a) a patient's refusal to take the medication (b) a decision not to administer the dose because of recognized contraindications. ... Timing Error - Administration of medication outside a predefined time interval from its scheduled administration time. ... Medication errors will be catalogued and review monthly in order analyze for patterns and trends...".

Review of the hospital policy titled "Patient and Non-Patient Notification Reporting Procedure", last revised 06/10, revealed, in part, " ...A patient and non-patient notification are mechanisms for recording unusual or adverse events. Such reports describe incidents that are not consistent with the routine operation of the hospital or the routine care of a particular patient ... When an unusual event occurs that deviates from the norm, a patient or non-patient notification is completed. If the event is medication related, a written form entitled "Medication Safety and Quality Report "should be completed and forwarded to risk management. ... Forms are to be accessed via the Meditech site under Risk Management. Each section (tab) should be completely filled out. ... Directors will receive an e-mail informing them a notification has been completed for their review. Directors should review the documented information and respond after investigation. The director should document the investigation completely in the " reviewed by managers " comment section. The director should then forward the comments electronically to risk management ..." .

Based on medical record review, policy review and interview the hospital failed to ensure the Registered Dietician supervise the Dietary Technician resulting in a missed dietary assessment for 1 of 18 random patients.( R14) Findings:

Review of the "Nutrition Re-assessment of Patients Policy #PE-A-063 presented as the hospitals current policy revealed in part, "Each Patient is reassessed at regular intervals as designated to determine a patient's response to care. Significant change in a patient's condition or diagnosis also results in reassessment. Procedure: 1. Reassessment will be completed on all inpatients as follows: No/Low/Mild Risk=rescreen within 5 days to determine if changes in nutritional status occur ... ".

The Medical Record for Patient R14 was reviewed. Documentation revealed Patient R14 was admitted on 12/29/09 with a diagnosis of Psychosis, Delirium and Urinary Tract Infection and discharged 01/15/10. . Review of the Initial Nursing Assessment revealed the Nutrition Evaluation was adequate with no to mild nutritional risk. Further review revealed the Dietary Technician assessed Patient R14 initially on 01/02/10 with no risk factor identified and zero nutritional risk. There was no documented evidence of a nutritional rescreen within five days after the initial screen to determine if changes in the nutritional status occurred.

S7, Registered Dietician (RD) was interviewed face to face on 07/12/10 at 1:30pm. S7 confirmed the 10 day nutritional screen was not done by the Dietary Technician.

S6, RD was interviewed face to face on 07/12/10 at 2:30pm. S6 indicated Patient R14's name had been omitted from the work assignment.

Based on observations and interviews with staff, the hospital failed to ensure that all facilities, supplies and equipment was maintained to ensure an acceptable level of safety and quality as evidenced by: 1) failing to ensure biohazard materials were store in a locked storage area with a missing biohazard identification label on the outside of the door and 2) failing to ensure floor mats in the therapy room were in good repair and cleanliness of the room. Findings:

1) failing to ensure biohazard materials were store in a locked storage area with a missing biohazard identification label on the outside of the door
Observation on the Telemetry/Cardiac unit on 07/07/10 at 9:15am revealed a soiled utility room, with the door unlocked, where biohazard bins were stored. There was no biohazard identification label on the outside of the door. S18, RN confirmed the findings and indicated the door remains unlocked because staff frequently go in and out of the area. S18 also indicated the public could enter the unlocked soiled storage area and further there were no biohazard labels on any of the soiled storage rooms hospital wide. The door on the Rehabilitation unit biohazard room was also observed at 11:10am without biohazard labels posted on the outside of door.

The hospital could not present a policy for the storage of biohazardous materials or a system for identifying storage rooms that contained biohazard materials.

2) failing to ensure floor mats in the therapy room were in good repair and cleanliness of the room
Observation on 07/07/10 at 11:10am revealed a mat in the therapy room with an approximate 3/8 " tear. Upon lifting the mat an accumulation of dust flew around the room. A 2nd mat, where patients sit, had an approximate 3/8" tear with exposed wood on the edge. This was confirmed by S18, RN.

Based on observation, record reviews, Tuberculosis Screening Policy, review of the Centers for Disease Control (CDS) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 and interviews, the hospital failed to: 1) develop a system to ensure all physicians were free of tuberculosis (TB) upon appointment and annually thereafter for 6 of 14 physicians' files reviewed from a total of 265 physicians appointed to the medical staff (S9, S10, S31, S32, S33, S43) and 2) ensure all personnel with direct patient contact were determined to be free of TB upon hire and annually thereafter for 2 of 32 personnel files reviewed (S44, S46); 3) ensure it maintained a sanitary physical environment as evidenced by a) having a dirty kitchen area, microwave, ice machine, Computer-On-Wheels (COWs), mattress, and pulse oximetry machine accessible to patients and family members during the stay on the medical surgical unit and b) having a contaminated area (lab draw station) stored with video equipment on the Radiation Oncology Unit used to educate the patients, and dirty linen stored in the bathroom on the Ambulatory Treatment Center (ATC) used by patients and family members on the unit. Findings:

1) System to ensure physicians were free of TB:
Review of the credentialing record for S9, MD revealed the last documented TB screening was done 04/28/08.
Review of the credentialing record for S10, MD revealed the last documented TB screening was done 06/24/08.
S28, Credentialing/Privileging Specialist was interviewed face-to-face on 07/07/10 at 2:45pm. S28 confirmed there were no current annual TB screenings for S9 and S10. S28 indicated the hospital ws getting TB screenings on the physicians at reappointment and not annually.
Review of Physician S31's credentialing file revealed the last documented TB was read on 06/05/08.

Review of Physician S32's credentialing file revealed the last documented TB was read on 11/07/08.

Review of Physician S33's credentialing file revealed the last documented TB was read on 07/05/07.

Review of Physician S34's credentialing file revealed he had received the BCG (Bacille bilie 'de Calmette-Guerin) vaccine in the past. Further review revealed no documented evidence of a chest x-ray or PPD (purified protein derivative) result as required by the medical staff bylaws. Further review revealed the tuberculosis screening had not been performed since 07/08/08.

Review of Physician S43's credentialing file revealed his TB screening was last documented on 12/26/08.

In a face-to-face interview on 07/08/10 at 8:55am, Credentialing and Privileging Specialist S28 indicated the hospital had no system in place to ensure the physicians were assessed annually to be free of TB. She further indicated the physicians were only required to submit TB test results or TB screening assessments every 2 years at the time of their appointment/reappointment.

In a face-to-face interview on 07/08/10 at 1:20pm, Manager of Medical Staff Services S38 indicated the physicians' PPD (purified protein derivative) was checked with their reappointment every two years. She further indicated if the TB had been tested within 24 months of the time of reappointment, the hospital did not require re-testing.

Review of the "Bylaws of the Medical and Dental Staff" , revised 12/10/09, revealed, in part, " ... Tuberculosis Screening & (and) Assessment ... Documentation of a screening & assessment for tuberculosis is a condition of appointment, reappointment and continued affiliation ... Each practitioner must provide a documentation of PPD testing done no less than every 24 months unless there is a documented history of positive PPD findings. Positive PPD reactors must provide evidence of a clear chest x-ray done within the last 10 years. ... A chest x-ray is required as baseline if PPD is positive, has recently converted, or practitioner has symptoms suggestive of active tuberculosis. ... A medical TB assessment will be requested thereafter. ... PPD or chest x-ray is required as baseline if BCG has been previously administered ... " .
Review of Centers for Disease Control Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 revealed in part, HCWs (Health Care Workers) refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in TB screening programs. All HCWs who have duties that involve face to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program. The following are HCWs who should be included in a TB screening program: ... Dental staff ... Physicians (assistant, attending, fellow, resident, or intern), including anesthesiologists, pathologists, psychiatrists, psychologists...
2) Personnel with annual TB testing:
Review of Director of Post-op Unit S44's personnel file revealed there was no documented evidence of the last annual TB screening done on the employee.
In a face-to-face interview with S8 DON (director of Nursing) on 7/8/10 at 5:20pm, S8 verified S44 did not have an annual TB screening in the personnel file. There was no documentation presented to the surveyor during the survey from 7/8/10 to 7/12/10 of S44's last annual TB screening. S8 CNO indicated all employees are required to have annual TB screenings performed.
Review of Director of Rehab S46's personnel file revealed the last TB screening was performed on 4/6/10 at 9:45am and read on 4/8/10 at 9:00am. The TB result was read prior to the 48 time frame. Further review revealed there was no documented evidence in S46's personnel file of a current TB screen for 2010.
In a face-to-face interview with S8 DON on 7/8/10 at 5:05pm, S8 verified S46's TB result read on 4/8/10 at 9:00am was prior to the 48 time frame. There was no documented evidence of S45's last TB screening presented to the surveyor from 7/8/10 through 7/13/10.
Review of the policy titled, "Tuberculosis Screening for Associates", Policy Number IC-F-130, last revised 10/02 and last reviewed 06/10 and presented as the hospital's current "TB" policy on 7/9/10 at 9:15am, read, " ...A consistent and effective method of the detection, control, and prevention of tuberculosis in hospital associates, ... III. ...A. Annually associates will undergo tuberculosis testing ...".

3) Sanitary physical environment
a) An observation of Unit 31 (U31) on 7/7/10 from 10:20am to 11:10am with S44 U31 Director, S8 CNO (Chief Nursing Officer) and S47, Housekeeping Manager revealed there was a kitchen area noted with brownish debris in the 4 sets of top kitchen cabinets, bottom kitchen cabinets, and kitchen drawers. Further observation revealed a microwave with a whitish/gray discoloration covering the door handle and brown specks on the inside wall panels of the microwave. There was an ice machine with a white cached substance around the 2 spouts, in the tray area, and on the back splash area of the machine. During this same observation, S44U31, Director reported the kitchen area is used by patients, family members, and staff. S44 indicated the kitchen cabinets, kitchen drawers, microwave, and ice machine were dirty. S8 CNO and S47, Housekeeping Manager confirmed the kitchen area was dirty during this observation. S49U31, Housekeeper agreed the kitchen area had dirty kitchen cabinets, kitchen drawers, microwave, and ice machine at 10:35am. S49 indicated she had cleaned all of the kitchen cabinets and drawers, microwave and ice machine last Friday, (7/2/10) 5 days ago. S49 further indicated she cleans the kitchen area as needed during the day shift and at the end of the shift everyday.

During the same tour of U31 on 7/7/10 from 10:40am to 10:50am with S44U31, Director revealed five (5) Computer-On-Wheels (COWs) labeled "50971" (#1); "50964" (#2); "51004" (#3); "50954" (#5); "50962" (#6) had a whitish/grayish debris on the top of the monitors, screen areas, sides of the keyboard panels, and the legs of the portable systems used by nursing staff during the shift to assess each patient. During this same tour, S44 U31 Director and S8DON confirmed the 5 COWs were dirty. S44 indicated the COWs are used by the nurses to document the patient's assessments during their shifts. She reported the COWs are to be cleaned after each patient's usage by the nurses, as needed when soiled and/or dirty, and terminally cleaned at the end of each shift. S44 indicated the nurses are not following the policy to keep the COWs clean.

Review of the policy titled, "Computer Cleaning and Disinfection Procedures", Policy Number IC-G-038, Issue Date: June 20, 2007, Approved Date: June 20, 2007, Revised Date: 07/08, 06/10, Reviewed Date: 07/08, 06/10, presented as the hospital's current "COW" cleaning procedure on 7/7/10 at 11:00am read, "...
1) All computers should be promptly cleaned by the user whenever visibly soiled...
2) ...Computer equipment stored on rolling stands, the disinfection of the equipment should be done at least each shift by the user...
3) Computers...contaminated...will be cleaned whenever visibly soiled...in addition to the routine schedule...a) Daily in patient rooms on general nursing units and with terminal room cleaning...
5) For cleaning computer equipment, use a disinfectant wipe or spray on a towel/cloth...Ensure that all high touch areas (keyboards, ...)...are disinfected...
7) Keyboard covers should be used...to simplify cleaning and disinfection process.

Dirty mattress:
In an interview on 7/7/20 at 11:00am, S44U31, Director was asked to bring the surveyor to a patient's room on U31 that was ready to admit a patient. S44 brought S8 CNO, S47, Housekeeping Manager and the surveyor. S44 indicated the room was clean and ready to admit a patient. This observation revealed there was a brown spot (dime sized) noted on the mattress under the clean sheets. During this observation, S44, S8, and S47 verified the mattress had a dirty spot. S44, S8 and S47 all indicated the mattress was dirty and not ready for patient use.

Dirty Pulse Oximetry:
On the same tour of U31 on 7/7/10 at 11:05am with S44U31, Director and S8 CNO, there was a pulse oximetry machine observed with a piece of satin tape that was grayish/black in color. S44 was asked by the surveyor to check her oxygen saturation with the machine. S44 was observed touching the grayish/black tape area with her left pointer finger and left middle finger. She confirmed she had touched the dirty piece of tape on the machine when she tested her oxygen saturation with the machine. She did not know why the tape was on the machine. She indicated the pulse oximetry machine should not have tape on it.

b) Contaminated area (lab draw station) stored with video equipment on Radiation Oncology Unit:
A tour of the Radiation Oncology Unit on 7/7/20 at 11:05am with S50 Radiation Oncology Director and S8DON revealed there was a small room with a right armed draw chair and lab supplies used to draw patient's blood work. Further observation revealed there was a cart with video equipment, (video screen and monitor) used for educating the patient's on the unit with the type of treatments (chemotherapy, radiation therapy) that would be administered to them. During this same observation, S50 and S8 both verified there were dirty blood supplies stored with clean video equipment used to educate the patients. S50 indicated there was not a lot of room on the unit to separate the two areas, dirty from clean. S50 reported some patients did take blood thinner medications. He agreed the video equipment was not clean after a patient's blood was drawn.

Dirty linen stored in the bathroom on ATC unit:
An observation of the ATC on 7/8/10 at 12:10pm with S36 ATC Director and S8 CNO revealed a dirty linen cart noted in the back right corner of the patient's bathroom. During this observation, S36 and S8 verified there was dirty linen stored in the patient's bathroom. S36 indicated there was no space to separate the dirty and clean areas.


25059






25065

Based on review of medical record, policy and procedure and staff interviews the hospital failed to ensure post-anesthesia evaluations had been performed for 4 of 4 sampled surgery patients out of 34 total medical records reviewed ( #4, #13, #16, #25) which has the potential to affect every patient inducted into anesthesia. Findings:

Patient #4
Review of the medical record revealed Patient #4 was admitted on 06/22/10 for a Total Hip Arthoplasty. Review of the PACU (Post Anesthesia Care Unit) Assessment revealed Patient #4's arrival to the unit was 9:40am. Review of the Pre Op Assessment revealed under informed consent dated 06/22/10 9:50am and signed by the CRNA "Tolerated Procedure." Review of the entire patient record revealed no documented evidence of a post-anesthesia evaluation which included an assessment of respiratory function, including respiratory rate, airway patency, oxygen saturation, cardiovascular function, including pulse rate and blood pressure, mental status, temperature, pain, nausea and vomiting; and postoperative hydration.

Patient # 13
Review of the anesthesia record for Patient # 13 revealed he had an a left Femoral-Popliteal By-Pass performed on 07/06/10 which began at 0650 (6:50am) and ended at 0953 (9:53am). Further review revealed no documented evidence Patient # 13 had been evaluated by either the CRNA (Certified Registered Nurse Anesthetist) or the Anesthesiologist within 48 hours post-anesthesia.
Review of the anesthesia record for Patient # 13 revealed he had an emergency exploration of the left leg performed on 07/06/10 which began at 1020 (12:20am) and ended at 1120 (11:20am). Further review revealed no documented evidence Patient # 13 had been evaluated by either the CRNA (Certified Registered Nurse Anesthetist) or the Anesthesiologist within 48 hours post-anesthesia.

Patient #16
Review of the anesthesia record for Patient # 16 revealed he had a left total knee arthroplasty performed on 07/06/10 which began at 1544 (3:44pm) and ended at 1755 (5:55pm). Further review revealed no documented evidence Patient # had been evaluated by either the CRNA (Certified Registered Nurse Anesthetist) or the Anesthesiologist within 48 hours post-anesthesia.

Patient #25
Review of the Anesthesia record for Patient #25 revealed she had a laparoscopic exam with an open cholecystectomy on 12/29/09 which began at 1355 (1:55pm) and ended at 1555 (3:55pm). Further review revealed no documented evidence Patient # had been evaluated by either the CRNA (Certified Registered Nurse Anesthetist) or the Anesthesiologist within 48 hours post-anesthesia.

Review of " Guidelines for Anesthesia Care " policy #100 and #105 and " Post-Anesthesia Care of the Patient " Policy #120 and #125, all last reviewed on 06/10 and submitted by the hospital as the one currently in use revealed no documented evidence requiring the CRNA or Anesthesiologist to perform a post-anesthesia evaluation within 48 hours after administration of an anesthetic.

Review of the PACU (Post Anesthesia Care Unit) Discharge Criteria, Policy #PACU 10, last reviewed 07/09 and submitted as the one currently in use revealed ..... " 1.1 The anesthesiologist is responsible for the discharge of the patient from PACU " .

In a face to face interview on 07/07/10 at 1:55pm S17, RN Surgical Services Educator indicated anesthesia has a written order to discharge patients from PACU according to criteria. Further S17 indicated there is no policy requiring anesthesia to evaluate the patient post-anesthesia.

In a face to face interview on 07/08/10 at 10:10am S48, RN Operating Room Director indicated post anesthesia evaluations were being done but review of systems was not documented. Further S48 there was no space on the anesthesia form to document the post anesthesia evaluation.

In a telephone interview on 07/08/10 at 3:25pm S9 Anesthesiologist/Surgery Section Chief indicated the anesthesia personnel see the patients once they are awake before they are discharged home or to the floor. Further she indicated the evaluation is usually documented on the anesthesia sheet titled " post anesthesia evaluation " . When the surveyor asked S9 if she was knowledgeable about what was required in the post-anesthesia evaluation assessment, and after S9 read the regulation, she indicated things at the hospital would have to be changed.







20177

Based on observation, record review, and interviews, the hospital failed to meet the Condition of Participation for Respiratory Services as evidenced by:

1) Failing to ensure the Medical Director of Respiratory Services (S32) performed the duties and responsibilities of his position as required by hospital policy as evidenced by the failure to ensure that all respiratory care orders were followed and administered to patients. There were 162 physician ordered respiratory treatments not performed from 04/01/10 through 04/15/10, 06/01/10 through 06/15/10, and 06/22/10 through 07/07/10 (see findings cited at 1153);

2) Failing to ensure the respiratory department had adequate staff to meet the needs of the patients for 2 weeks in April (04/01/10 through 04/15/10) and 24 days in June and July (06/01/10 through 06/15/10 and 06/22/10 through 07/07/10) which resulted in 162 missed dosages of physician ordered respiratory medication/treatments (see findings cited at 1154); and

3) Failing to ensure all respiratory treatments were administered to patients as ordered by physicians for 2 of 20 patients reviewed for respiratory treatment administration from a total of 34 sampled patients (#15, #26); 9 of 16 random patients reviewed for respiratory treatment administration from a total of 18 random patients (#R1, #R3, #R4, #R5, #R6, #R13, #R15, #R16, #R17); 34 missed treatments from 04/01/10 through 04/15/10; and 23 missed treatments from 06/01/10 through 06/15/10 (see findings cited at 1163).

Based on review of the physician credentialing files, medical record review, and interviews, the hospital failed to ensure the Medical Director of Respiratory Services (S32) performed the duties and responsibilities of his position as required by hospital policy as evidenced by 162 missed dosages of respiratory treatments from 04/01/10 through 04/15/10, 06/01/10 through 06/15/10, and 06/22/10 through 07/07/10. Findings:

Review of Physician S32's credentialing file revealed he was reappointed to the medical staff on 01/01/10 as a pulmonologist and was privileged as the Director of Respiratory Services.

Review of patient medical records and lists of missed respiratory treatments provided by Director of Respiratory S40 revealed 157 missed respiratory treatments from 04/01/10 through 04/15/10, 06/01/10 through 06/15/10, and 06/22/10 through 07/07/10 (see findings cited at 1163).

In a telephone interview on 07/13/10 at 9:10am, Medical Director of Respiratory Services S32 confirmed he was the Medical Director of Respiratory Services. He indicated he was not aware there had been 162 missed visits. S32 confirmed he did not write the triage or prioritization policies, and he was not involved in the revision of the triage policy in 03/10. He indicated he could not answer any questions related to staffing of the respiratory department, as his role was to interpret pulmonary function tests, give advice in medical emergencies, answer questions about treatments/medications, suggest types of respirators to purchase, and suggest the type of spirometry to use. He further indicated he was not involved with the quality improvement of the respiratory department; he saw his role as that of a consultant. When questioned about the number of missed treatments, he confirmed he was not notified that treatments were being missed. He further indicated patients don't get their treatments as ordered at home, so they're at least getting more at the hospital than at home.

In a face-to-face interview on 07/13/10 at 9:25am, Vice-President of Medical Staff S13, after having heard the phone interview with Medical Director of Respiratory Services S32, indicated S32 would be expected to perform his duties and responsibilities as the Respiratory Medical Director, or he (S13) would replace him.

Review of the hospital policy titled "Medical Director, Respiratory Care Services", last revised 05/07 and presented as the hospital's current policy,revealed, in part, " ... Policy Statements: 1. Medical direction is provided on a full time basis by a member of the Medical staff. The physician medical directed possess expertise in the management of patients with respiratory impairments ... 2. The Medical Director is responsible for the following: 2.1 Works directly with the RC (respiratory care) Department Director and leadership team in assuring that department policies, protocol and procedures are appropriate and adhered to b providing overall direction in the provision of services in the inpatient and clinic settings. 2.2 Assures that the quality, safety, and appropriateness of respiratory care services are monitored and evaluated and that appropriate actions based on findings are taken. 2.3 Is held accountable by the medical staff for the quality and appropriateness of respiratory services. 2.4 Is held accountable by the medical staff for the provision of technology needed to administer respiratory services. 2.5 Provides medical oversight and serves as a resource to identify performance improvement opportunities. 2.6 Provides/oversees training and in-services on a periodic basis to insure that the staff is current in pulmonary medicine and procedures. 2.7 Provides consultation/teaching to staff members. 2.8 Provides input to the Director relating to staffing, budget, capital equipment, personnel selection and staff performance ... ".

Based on observation, record review, and interview, the hospital failed to ensure the respiratory department was staffed to meet the needs of the patients for 2 weeks in April (04/01/10 through 04/15/10) and 24 days in June and July (06/01/10 through 06/15/10 and 06/22/10 through 07/07/10) which resulted in 162 missed dosages of respiratory medication/treatments. Findings:

Observation on 07/08/10 at 3:20pm revealed Respiratory Therapist (RT) S45 did not administer the scheduled respiratory treatment for Patient #15, who was a patient in ICU (intensive care unit).

In a face-to-face interview on 07/08/10 at 3:20pm, RT S45 indicated she was the only RT in ICU at the time, and they were short-staffed. She further indicated she had patients on ventilators, she had just finished extubating a patient, and Patient #15 was not triaged as a critical patient.

Medical record review revealed 2 omissions (missed doses) of Proventil nebulizer treatments and 2 omissions of Atrovent nebulizer treatments for Patient #R1 from 07/07/10 - 07/12/10 (see findings cited at 1163).

Medical record review revealed 7 omissions of Atrovent and 7 omissions of Proventil for Patient #R3 from 07/02/10 - 07/05/10 (see findings cited at 1163).

Medical record review revealed 16 omissions of Proventil for Patient #R4 from 06/26/10 - 07/02/10 (see findings cited at 1163).

Medical record review revealed 6 omissions of Proventil and 5 omissions of Atrovent for Patient #R5 from 07/06/10 - 07/11/10 (see findings cited at 1163).

Medical record review revealed 17 omissions of Xopenex for Patient #R6 from 06/30/10 - 07/10/10 (see findings cited at 1163).

Medical record review revealed 2 omissions of Proventil and 2 omissions of Atrovent for Patient #26 from 07/01/10 - 07/07/10 (see findings cited at 1163).

In a face-to-face interview on 07/12/10 at 3:25pm, Information Technology Registered Nurse S27 confirmed the above findings.

Medical record review revealed 17 omissions of Atrovent and 16 omissions of Proventil for Patient #R13 from 06/24/10 - 07/07/10 (see findings cited at 1163).

Medical record review revealed 2 omissions of Proventil and 1 omission of Atrovent for Patient #R15 from 07/04/10 - 07/05/10 (see findings cited at 1163).

Medical record review revealed 1 omission of Atrovent on 06/18/10 for Patient #R16 (see findings cited at 1163).

Medical record review revealed 1 omission of Albuterol on 06/18/10 for Patient #R17 (see findings cited at 1163).

In a face-to-face interview on 07/12/10 at 5:00pm, Director of Respiratory S40 confirmed the above findings.

Review of the list of " missed treatment from 06/01/10 through 06/15/10 " , presented by Director of Respiratory S40, revealed a total of 23 missed treatments.

Review of the list of " missed treatment from 04/01/10 through 04/15/10 " , presented by Director of Respiratory S40, revealed a total of 34 missed treatments.

No medication variance reports were presented by the hospital for the above missed respiratory treatments.

In a face-to-face interview on 07/09/10 at 9:05am, Director of Respiratory S40 indicated an occurrence report is not completed by staff if a respiratory treatment is missed. She further indicated if a respiratory treatment is given late, greater than 2 hours from the ordered time, an occurrence report is completed, because that would be considered a medication error.

In a face-to-face interview on 07/13/10 at 8:35am, Director of Respiratory S40 indicated she felt her department was adequately staffed, but she could give no explanation for the number of missed respiratory treatments. She indicated the other duties (other than respiratory treatments) of the respiratory therapist include ventilator checks every 2 hours, BiPAP/CPAP (continuous positive airway pressure) checks every 4 hours if not nocturnal (if nocturnal, it's done every 4 hours starting at 10:00pm - 7:00am), suctioning patients, responds to all rapid response calls and code blues (code blue is an arrested patient; rapid response is a change in a patient's condition that a nurse calls the response team to prevent arrest), transports ventilated or high-acuity patients between procedures, routine chest physiotherapy, instructs patients on incentive spirometry, performs hospital-wide blood gases ordered, and performs pulmonary function tests. S40 indicated the policy was for a RT to have 10-12 patients, so a 2 hour window (2 hours before or after the scheduled ordered time for administration) was allowed for administration (S40 gave example of 12 patients with 8:00am treatment ordered). She further indicated the triage policy addressed the treatment that couldn't be given due to the RT being involved with a code. When asked by the surveyor what was the difference between the triage policy and the priority of care policy addressed in the medical staff bylaws, S40 indicated the priority care was for times that staff would call in, such as less than scheduled adequate staff.

In a telephone interview on 07/13/10 at 9:10am, Medical Director of Respiratory Services S32 confirmed he was the Medical Director of Respiratory Services. He indicated he was not aware there had been 162 missed visits. He indicated that he would expect the physician to be notified if more than 2 respiratory treatments per day were missed. When asked what the medical staff bylaws referred to when stating in the priority of care policy for "floors" only, S32 confirmed the ICU (intensive care unit) should not be included in prioritizing care. S32 confirmed he did not write the triage or prioritization policies, and he was not involved in the revision of the triage policy in 03/10. He indicated he could not answer any questions related to staffing of the respiratory department, as his role was to interpret pulmonary function tests, give advice in medical emergencies, answer questions about treatments/medications, suggest types of respirators to purchase, and suggest the type of spirometry to use. He further indicated he was not involved with the quality improvement of the respiratory department; he saw his role as that of a consultant. When asked by the surveyor what he considered a medication error for respiratory treatment, S32 indicated it would be a treatment missed greater than 2 times a day, a wrong dose of medication, or a wrong medication. He further indicated patients don't get their treatments as ordered at home, so they're at least getting more at the hospital than at home.

In a face-to-face interview on 07/13/10 at 1:00pm, Director of Respiratory S40 indicated she doesn't keep the assignment sheets that show the use of the respiratory staffing matrix. She could provide no documented evidence of the assignment of staff according to the staffing matrix.

Review of the hospital policy titled "Respiratory Care Time Standards", last revised 03/09, revealed, in part, "...Services will be rendered as close to the time standards as possible, although the fact that a single RCP (respiratory care practitioner) is assigned as many as 10-12 patients makes it impossible to provide all treatments at the exact prescribed time. The therapist may stagger treatment times to keep the intervals between treatments appropriate. The general expectation is that treatments will be given within two hours before or after the targeted treatment time ...".

Review of the hospital policy titled "Department of Respiratory Care Staffing Matrix", last reviewed 01/10, revealed, in part, "...Scheduling of staff in the Respiratory Care Department will be based on patient status and the staffing matrix. ...Policy Staffing will occur on a shift by shift basis. Each procedure is assigned a point value. The matrix designates the number of procedures assigned to each staff member. The number of staff members working on each shift is determined by the total procedural count. There will be a minimum of two respiratory care practitioners on each shift. ... Procedure I' Staffing A. An entry on the Treatment Master Sheet is completed for each new patient documenting the treatments/procedures ordered by the physician. B. A weighted system of 0.22 hour is used to assign a point value to each treatment. ... D. The Charge Therapist will use the Treatment Master Sheet to calculate the treatment load before shift change ... D. A staffing matrix is provided to determine how many therapists are needed per shift. E. The Charge Therapist will notify the Department when additional staffing is required. ... II. Assignments ... C. The Charge Therapist is responsible for assuring the completion of all tasks prior to allowing staff members to leave. D. Assignment guidelines 1. Clinical areas should be staffed to matrix in the following order (note: more than one area may be assigned) a. ICCU (intensive care cardiac unit) b. ER (emergency room) c. Pediatrics d. Floor therapy 2. ER and the pediatric unit should be assigned to separate therapists if possible. 3. The Pulmonary Function Technician may be assigned procedures if the count for PFTs doesn't exceed 30 ...".

Review of the "Bylaws for the Medical and Dental Staff", with a revision date of 12/10/2009, revealed, in part, "... Section 10 Rules and Regulations for the Respiratory Department ... 1. Prioritization Policy and Procedure A. Purpose: To assure that those patients most in need of therapy receive ordered treatments. B. Treatments should be allocated in the following manner when operational factors dictate that some bronchial hygiene procedures may be missed. The highest priority will be patients in Category #1 with priority decreasing in descending order. 1. a. Patients acutely short of breath or with acute airway obstruction. b. Patients requiring sputum induction prior to initiation of antibiotic therapy. 2. a. Patients chronically short of breath. b. Patients at high risk for developing atelectasis (especially those postop abdominal and thoracic patients with decreased sensorium). 3. Patients bringing up sputum. 4. Patients not meeting above criteria but with a bronchodilator ordered. 5. Routine postop patients (patients who have not has thoracic or abdominal surgery). 6. Patients not meeting above criteria who have normal saline nebulizers ordered. C. When treatments are missed due to prioritization, the Respiratory Care Practitioner will alert the relevant nursing and medical staff. D. Assignment of priority of therapy shall be performed by certified technicians and above. This Plan applies to bronchial hygiene procedures on the "floor" only. Other critical modalities (e.g., ventilator patents, newborn care, blood gases, pulmonary functions) are not subject to prioritization ...".

Review of the hospital policy titled "Respiratory Care Service Triage of Resources", last revised 03/10, revealed, in part, "...The triage policy provides specific guidelines related to those periods which the quantity of work exceeds resources available. Such situations may occur in the event of acute increases in work demand, or in situations of acute staff shortages as a result of the inability of staff to report to work. 3. The triage procedure can be activated by the Charge Therapist. ... 1. Procedure The need to activate RC (respiratory care) triage should first be assessed. In the event an RCP (respiratory care practitioner) experiences acute increases in work demand and is unable to provide the requested and necessary care, they will contact the team leader to report the situation. The team leader will make an assessment of any other fluctuations in work demand and the ability to cross utilize RCP resources from other areas of the hospital. ... The following procedures can be deferred for a 24-hour period: Equipment change aerosol, Equipment change ventilator, Equipment change BiPAP/CPAP, Ballard cath change ... Treatment frequencies for chest physiotherapy maneuvers and supervised incentive spirometry can be changed from QID (4 times a day) to BID (2 times a day). Ventilator checks can be changed from Q3 hours (every 3 hours) to Q4 hours (every 4 hours) for patients that have been stable over the past 24 hours and are not requiring high levels of support... 2. Any interventions missed as a result of the triage task must be reported to the other primary care givers through the patients nurse. Such therapy omission will also be documented in Meditech with the reason not done. 3. If after the progressive implementation of the above measures the team leader or staff, do not have the necessary resources available the Director or Medical Director of the department will be contacted".

Review of the hospital policy titled "Medical Director, Respiratory Care Services", last revised 05/07 and presented as the hospital's current policy,revealed, in part, "... Policy Statements: 1. Medical direction is provided on a full time basis by a member of the Medical staff. The physician medical directed possess expertise in the management of patients with respiratory impairments ... 2. The Medical Director is responsible for the following: 2.1 Works directly with the RC (respiratory care) Department Director and leadership team in assuring that department policies, protocol and procedures are appropriate and adhered to b providing overall direction in the provision of services in the inpatient and clinic settings. 2.2 Assures that the quality, safety, and appropriateness of respiratory care services are monitored and evaluated and that appropriate actions based on findings are taken. 2.3 Is held accountable by the medical staff for the quality and appropriateness of respiratory services. 2.4 Is held accountable by the medical staff for the provision of technology needed to administer respiratory services. 2.5 Provides medical oversight and serves as a resource to identify performance improvement opportunities. 2.6 Provides/oversees training and in-services on a periodic basis to insure that the staff is current in pulmonary medicine and procedures. 2.7 Provides consultation/teaching to staff members. 2.8 Provides input to the Director relating to staffing, budget, capital equipment, personnel selection and staff performance ...".

Based on observation, record review, and interviews, the hospital failed to ensure respiratory treatments were administered as ordered for 2 of 20 patients reviewed for respiratory treatment administration from a total of 34 sampled patients (#15, #26), for 9 of 16 random patients reviewed for respiratory treatment administration from a total of 18 random patients (#R1, #R3, #R4, #R5, #R6, #R13, #R15, #R16, #R17), for 34 missed treatments from 04/01/10 through 04/15/10 (evidenced by a list if missed treatments provided by the hospital), and 23 missed treatments from 06/01/10 through 06/15/10 (evidenced by a list if missed treatments provided by the hospital). Findings:

Patient #15
Observation on 07/08/10 at 3:20pm revealed Respiratory Therapist (RT) S45 did not administer the scheduled respiratory treatment for Patient #15, who was a patient in ICU (intensive care unit).
In a face-to-face interview on 07/08/10 at 3:20pm, RT S45 indicated she was the only RT in ICU at the time, and they were short-staffed. She further indicated she had patients on ventilators, she had just finished extubating a patient, and Patient #15 was not triaged as a critical patient.

Patient #26
Review of Patient #26's physician orders for the admission of 06/17/10 revealed the following orders:
06/18/10 at 8:15am - Albuterol 2.5 mg (milligrams) and Atrovent 0.5 mg per nebulizer every 6 hours and prn (as needed), with no documented evidence of the symptoms that would require the prn dosage;
06/19/10 - Xopenex 0.63 mg QID (4 times a day) and prn SOB (shortness of breath) and Pulmozyme 2.5 mg BID (twice a day) and prn SOB.
Review of the "Edit MAR" (computerized medication administration record) revealed the Atrovent was administered on 06/18/10 at 1533 (3:33pm) and at 1924 (7:24pm), less than 4 hours between administration when the order was for every 6 hours. Further review revealed the Albuterol was administered on 06/19/10 at 8:00am and 1314 (1:14pm), less than 6 hours between administration.
Review of the "Edit MAR" revealed Xopenex was scheduled for 8:00pm on 06/23/10 and was administered on 06/24/10 at 2:03am, which was more than 6 hours late. Further review revealed the scheduled 7:00am dose of Xopenex on 06/24/10 was administered at 9:39am, more than 2 ? hours late. Further review revealed the 8:00pm scheduled dose on 06/26/10 was administered at 5:10am on 06/27/10, more than 9 hours late; the 7:00am dose for 06/27/10 was administered at 6:38am, only 1 hour 28 minutes after the previously administered dose.
Review of the "Edit MAR" revealed Pulmozyme was administered on 06/20/10 at 6:56am and 7:21am with no documented evidence of the reason for the second administration.
Review of Patient #26's physician's orders for the admission of 06/30/10 revealed the following orders:
06/30/10 at 1645 (4:45pm) - Xopenex 0.63 mg/3 ml (milliliters) QID per neb (nebulizer) & (and) prn; Atrovent 0.5 mg/2.5 ml QID per neb;
07/01/10 at 1455 (2:55pm) Therapeutic Interchange by pharmacist for Albuterol 2.5 mg to substituted for Xopenex 0.63 mg.
Review of the MARs for Patient #26 revealed Albuterol and Atrovent were not administered on 07/02/10 at 11:00am and 07/03/10 at 7:00am due to "triage".

Patient #R1
Review of Patient #R1's physician orders on 07/07/10 at 1700 (5:00pm) revealed an order for Aerosol with Duonebs QID.
Review of Patient #R1's MAR revealed no documented evidence Albuterol 2.5 mg and Atrovent 0.5 mg were administered on 07/08/10 at 4:00pm and on 07/09/10 at 11:00am.

Patient #R3
Review of Patient #R3's physician orders revealed an order on 07/01/10 at 2014 (8:14pm) for Neb tx (treatment) Atrovent/Proventil every 4 hours prn SOB.
Review of the MARs for Patient #R3 revealed no documented evidence Atrovent and Proventil were administered as ordered on 07/02/10 at 12:00am, 07/02/10 at 12:00pm, 07/03/10 at 12:00am, 07/03/10 at 4:00am, 07/03/10 at 12:00pm, 07/04/10 at 4:00am, and 07/05/10 at 8:00am.

Patient #R4
Review of Patient #R4's physician orders revealed an order on 06/24/10, with no documented evidence of the time the order was written, for Albuterol 0.083% (per cent) - 3 cc (cubic centimeters) per nebulizer QID.
Review of Patient #R4's MARs revealed no documented evidence Albuterol was administered on 06/26/10 at 11:00am; 06/27/10 at 4:00pm; 06/28/10 at 7:00am, 11:00am, 4:00pm, and 8:00pm; 06/29/10 at 7:00am, 11:00am, 4:00pm, and 8:00pm; 06/30/10 at 4:00pm; 07/01/10 at 11:00am; 07/02/10 at 7:00am, 11:00am, and 4:00pm; and 07/03/10 at 4:00pm.

Patient #R5
Review of Patient #R5's physician orders revealed an order on 07/06/10 at 2:05pm for Albuterol 2.5 mg/Atrovent 0.5 mg now and every 4 hours.
Review of Patient #R5's MARs revealed no documented evidence Atrovent was administered as ordered on 07/06/10 at 1419 (2:19pm), )7/06/10 at 4:00pm, and 07/07/10 at 4:00am, 12:00pm, and 4:00pm. Further review revealed no documented evidence Albuterol was administered as ordered on 07/06/10 at 2:19pm and 4:00pm, on 07/07/10 at 4:00am and 4:00pm, 07/10/10 at 4:00am, and 07/11/10 at 4:00am.

Patient #R6
Review of Patient #R6's physician orders revealed an order on 06/30/10 at 10:50am for Xopenex 1.25mg/Atrovent 0.5 mg neb QID.
Review of Patient #R6's MARs revealed no documented evidence Xopenex was administered for 2 treatments on 06/30/10, 2 treatments on 07/01/10, 4 treatments on 07/02/10, and 4 treatments on 07/03/10. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:30pm. Further review revealed no documented evidence Xopenex was administered as ordered on 07/04/10 at 4:00pm, 07/07/10 at 12:00am and 8:00am, 07/09/10 at 12:00am, and 07/10/10 at 12:00am.

In a face-to-face interview on 07/12/10 at 3:25pm, Information Technology Registered Nurse S27 confirmed the above findings.

Patient #R13
Review of Patient #R13's physician orders revealed an order on 06/21/10 at 2:35am for Neb txs 0.5 mg Atrovent and 2.5 mg Albuterol every 4 hours starting at 8:00am.
Review of the MARs for Patient #R13 revealed no documented evidence Atrovent was administered as ordered on 06/24/10 at 4:00pm; 06/26/10 at 8:00am, 12:00pm, and 10:00pm; 06/28/10 at 12:00pm and 8:00pm; 06/29/10 at 12:00am, 8:00am, and 12:00pm; 06/30/10 at 12:00am; 07/01/10 at 4:00am; 07/02/10 at 4:00am and 12:00pm; 07/04/10 at 12:00pm; 07/05/10 at 8:00am; 07/06/10 at 12:00am; and 07/07/10 at 4:00am. Further review revealed no documented evidence Albuterol was administered as ordered on 06/24/10 at 4:00pm; 06/26/10 at 8:00am, 12:00pm, and 8:00pm; 06/28/10 at 8:00pm; 06/29/10 at 12:00am, 8:00am, and 12:00pm; 06/30/10 at 12:00am; 07/01/10 at 4:00am; 07/02/10 at 4:00am and 12:00pm; 07/04/10 at 12:00pm; 07/05/10 at 8:00am; 07/06/10 at 12:00am; and 07/07/10 at 4:00am. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:25pm.

Patient #R15
Review of Patient #R15's physician orders revealed an order on 07/04/10 for Albuterol 2.5 mg/Atrovent 0.5 mg QID & prn.
Review of Patient #R15's MARs revealed no documented evidence Albuterol was administered as ordered on 07/05/10 at 11:00am and 2217 (10:17pm). Further review revealed no documented evidence Atrovent was administered as ordered on 07/05/10 at 11:00am. These findings were confirmed by Director of Respiratory S40 on 07/12/10 at 4:45pm.

Patient #R16
Review of Patient #R16's physician orders revealed an order on 06/18/10 at 6:05am for Albuterol 2.5 mg every 4 hours. Review of the MAR revealed it was not administered for greater than 4 hours after it was ordered. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:05pm.

Patient #R17
Review of Patient #R17's physician orders revealed an order on 06/18/10 at 11:07am for Albuterol neb 2.5 mg now x (times) 3 doses. Review of the MAR revealed no documented evidence of the final dose being administered. This was confirmed by Director of Respiratory S40 on 07/12/10 at 4:05pm.

Review of the list of "missed treatment from 04/01/10 through 04/15/10" , presented by Director of Respiratory S40 as the list of respiratory treatments missed for this period of time, revealed a total of 34 missed treatments.

Review of the list of "missed treatment from 06/01/10 through 06/15/10", presented by Director of Respiratory S40 as the list of respiratory treatments missed for this period of time, revealed a total of 23 missed treatments.

No medication variance reports were presented by the hospital for the above missed respiratory treatments.

In a face-to-face interview on 07/09/10 at 9:05am, Director of Respiratory S40 indicated an occurrence report (medication variance) is not completed by staff if a respiratory treatment is missed. She further indicated if a respiratory treatment is given late, greater than 2 hours from the ordered time, an occurrence report is completed, because that would be considered a medication error. She could offer no explanation for having no variance reports for the treatments that were administered outside the 2 hour time frame.

In a face-to-face interview on 07/13/10 at 8:35am, Director of Respiratory S40 could give no explanation for the number of missed respiratory treatments. She confirmed there were no medication variance reports submitted for the missed treatments.

In a telephone interview on 07/13/10 at 9:10am, Medical Director of Respiratory Services S32 indicated he was not aware there had been 162 missed visits. He indicated that he would expect the physician to be notified if more than 2 respiratory treatments per day were missed. When asked what the medical staff bylaws referred to when stating in the priority of care policy for "floors" only, S32 confirmed the ICU (intensive care unit) should not be included in prioritizing care. S32 confirmed he did not write the triage or prioritization policies, and he was not involved in the revision of the triage policy in 03/10. He indicated he was not involved with the quality improvement of the respiratory department; he saw his role as that of a consultant. When asked by the surveyor what he considered a medication error for respiratory treatment, S32 indicated it would be a treatment missed greater than 2 times a day, a wrong dose of medication, or a wrong medication. He further indicated patients don't get their treatments as ordered at home, so they're at least getting more at the hospital than at home.

In a face-to-face interview on 07/13/10 at 9:35am, Director of Pharmacy S21 indicated pharmacy tracked and looked at respiratory treatments as a drug utilization review. She further indicated they looked at Xopenex and Albuterol in late Aril and early May 2010. When asked a second time about the review performed, S21 confirmed that what she had identified was treatments missed due to the patient being unavailable and due to no reason given by the RT or for being triaged. When asked what she considered a medication error, S21 indicated she would look for a trend of the treatment being given outside the 2 hour window allowed for administration, and an error would be if no reason was documented for missing the treatment. She further indicated she would not consider a triaged respiratory treatment as a medication error. In a later interview on the same day at 10:50am, S21 confirmed the audit performed by pharmacy in April 2010 did not focus on missed treatments.

In a face-to-face interview on 07/13/10 at 1:00pm, Director of Respiratory S40 indicated the RT (respiratory therapist) triages the patient, that is, if the RT was busy with a code or critical patient, the other patient's scheduled treatment would be missed because of triaging. She further indicated the RT should be reporting any triaged treatment to the nurse, but she couldn't be sure that this report was documented each time. S40 indicated she is notified as the director of the unit, but the Medical Director is not notified. She confirmed that the RTs were not completing medication variances for triaged missed treatments. After reviewing the medication error policy as requested by the surveyor, S40 confirmed that the RTs were not following hospital policy for missed respiratory treatments.

In a face-to-face interview on 07/13/10 at 1:25pm, Director of Nursing S8 indicated the respiratory therapists were telling the nurses when treatments were missed, but that the majority of the time the nurses were not calling the physician when respiratory treatments were missed. She further indicated she was not aware until the present time of this interview that the hospital policy required the nurse to notify the physician when respiratory treatments were missed.

Review of the hospital policy titled "Respiratory Care Time Standards", last revised 03/09, revealed, in part, " ...Services will be rendered as close to the time standards as possible, although the fact that a single RCP (respiratory care practitioner) is assigned as many as 10-12 patients makes it impossible to provide all treatments at the exact prescribed time. The therapist may stagger treatment times to keep the intervals between treatments appropriate. The general expectation is that treatments will be given within two hours before or after the targeted treatment time ...".

Review of the hospital policy titled "Respiratory Care Service Medication Errors", last revised 03/10, revealed in part, "... A medication error reporting program is mandated by JCAHO (Joint Commission Accreditation of Health Care Organizations) and is a function that all RCPs (respiratory care practitioners) administering medications is held accountable. By reporting errors, changes can be made in treatment to minimize the potential for adverse response and identify opportunities for improvement. Reporting is a voluntary and accomplished through both the Med-error form and delivered to risk management. Definition: A medication error is defined as any preventable medication related event that may lead to inappropriate use or cause patient harm. Such events may be related to professional practice, procedures, or systems. The medication use process includes prescribing, order communication, dispensing, distribution, administration, patient education and monitoring response. The RCP (Respiratory Care Practitioner) may observe an error or omission in any of the process identified. Policy Statement: 1. The medication error policy for RC incorporates the identification and reporting of events that include: a. Adverse response to aerosolized medications (as detailed in the policies for aerosol medications) b. Errors in type, dose, or timing of administration c. Missed therapies i. PRN treatments are excluded from missed therapy counts ii. A therapy is considered missed if the RCP is not able to perform it by the end of the shift in which it is due. (Ex: If a treatment is scheduled to be given every 4 hours, but the next treatment is not given until 8 hours later it would be considered a missed treatment). 2. The RCP will document all medication errors in meditech. 3. Meditech provides for the entry of any treatment not started and the capture of the reason why. Meditech provides for the entry of adverse response and the capture of the observation. a. As per hospital policy, for any medication that is not given or late, the RCP must also complete a medication error form and report it to the RC Director".
Review of the hospital policy titled "Respiratory Care Service Triage of Resources", last revised 03/10, revealed, in part, "...The triage policy provides specific guidelines related to those periods which the quantity of work exceeds resources available. Such situations may occur in the event of acute increases in work demand, or in situations of acute staff shortages as a result of the inability of staff to report to work. 3. The triage procedure can be activated by the Charge Therapist. ... 1. Procedure The need to activate RC (respiratory care) triage should first be assessed. In the event an RCP (respiratory care practitioner) experiences acute increases in work demand and is unable to provide the requested and necessary care, they will contact the team leader to report the situation. The team leader will make an assessment of any other fluctuations in work demand and the ability to cross utilize RCP resources from other areas of the hospital. ... The following procedures can be deferred for a 24-hour period: Equipment change aerosol, Equipment change ventilator, Equipment change BiPAP/CPAP, Ballard cath change ... Treatment frequencies for chest physiotherapy maneuvers and supervised incentive spirometry can be changed from QID (4 times a day) to BID (2 times a day). Ventilator checks can be changed from Q3 hours (every 3 hours) to Q4 hours (every 4 hours) for patients that have been stable over the past 24 hours and are not requiring high levels of support... 2. Any interventions missed as a result of the triage task must be reported to the other primary care givers through the patients nurse. Such therapy omission will also be documented in Meditech with the reason not done. 3. If after the progressive implementation of the above measures the team leader or staff, do not have the necessary resources available the Director or Medical Director of the department will be contacted".

Review of the hospital policy titled "Medication Errors (Medication System Failures)", last revised 01/09, revealed, in part, "Policy The Department of Pharmacy Services shall establish and participate in a multidisciplinary quality improvement program that documents and assesses medication system failures. ... Medication errors are failures in the medication use system that allow patients to be exposed to drug therapies that have mistakes in prescribing, dispensing, administration, and patient compliance. ...Types of medication errors include: ... Omission Error - The failure to administer an ordered dose to a patient before the next scheduled dose. Excluded are (a) a patient's refusal to take the medication (b) a decision not to administer the dose because of recognized contraindications. ... Timing Error - Administration of medication outside a predefined time interval from its scheduled administration time. ... Medication errors will be catalogued and review monthly in order analyze for patterns and trends...".