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Tag No.: A0043
Based on staff interview and document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution when:
1. The hospital's Medical Staff Bylaws, rules and regulations were not followed; 86 of 224 physicians were not reappraised for competence prior to being reappointed; one physician was not reappraised as required on a biennial basis; one of eight credential files reviewed indicated a physician was granted active status without having been regularly involved in the care of twelve or more patients. (refer to A 47, A 340, A 353)
2. No Quality Assessment and Performance Improvement (QAPI) program was established and on-going. No QAPI projects were identified and the hospital did not provide data documenting an on-going program of quality improvement and patient safety was in place. (Refer to A 283, A 309)
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
Tag No.: A0047
Based on staff interviews and administrative document review; the hospital failed to verify that the medical staff operated under the medical staff bylaws, rules and regulations that had been approved by the governing body when 86 physicians were not reappraised for competence prior to being reappointed, one physician was not reappointed on a biennial basis and one out of eight credential files reviewed revealed a physician was granted active staff status without having been regularly involved in the care of twelve or more patients. These failures placed patients at a potential risk of receiving care that was not in accordance with the medical staff bylaws and medical staff rules and regulations.
Findings:
On 8/5/13 at 1:30 p.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 50 "10.3 MEDICAL EXECUTIVE COMMITTEE, 10.3-2 DUTIES The duties of the Medical Executive Committee shall include, but not be limited to: (h) Reviewing the qualifications, credentials, performance and professional competence, and character of applicants and staff members, and making recommendations to the Board of Directors at least quarterly regarding staff appointments and re-appointments, assignments to services, clinical privileges, and corrective action";
It indicated on page 52 "10.4 MEDICAL STAFF PROFESSIONAL PRACTICE COMMITTEE 10.4-2 DUTIES (a) The Medical Staff Professional Practice Committee will assume the Medical Staff credentialing function. The Committee will review and evaluate the qualifications of each practitioner applying for initial appointment , reappointment, or modification of clinical privileges, and, in connection therewith, obtain and consider the recommendations of the appropriate services";
It indicated on page 5 "3.2 ACTIVE STAFF 3.2-1 QUALIFICATIONS The active staff shall consist of members who: (c) Regularly admit, or otherwise are regularly involved in the care of in excess of 12-patients a year in the hospital; or are regularly involved in Medical Staff functions, as determined by the Medical staff."
On 8/5/13 at 2:00 p.m., Medical Staff Coordinator 3 (MSC 3) was interviewed. She stated Medical Staff reappointments had been made during a period which extended from November 12, 2012 thru the last cycle which ended April 8, 2013 without the reappointees being reappraised for competence. She stated there was no process by which, with which or thru which Medical Staff members who had previously been granted privileges were reappraised for competence prior to being reappointed. She stated the Director of Clinical Services, Registered Nurse 1 (RN 1) and the Chief Executive Officer (CEO 2) were aware of the situation. She stated she did not have the staff or the tools to conduct substantive biennial reappraisals prior to reappointments.
On 8/6/13 at 9:00 a.m. Medical Staff credential files were reviewed with MSC3. Review of the credential files revealed 1 (one) out of a total of eight (eight) practitioner's credential files which showed no evidence of regular admissions or regular involvement in the care of in excess of 12 patients a year in the hospital (MD 6). An activity report for MD 6 revealed he had been involved in the care of only 3 (three) patients during a period extending from 8/6/10 thru 8/6/13. MSC 3 stated MD 6 was on the Medical Staff and was listed in the ACTIVE staff category. She stated MD 6 did not meet the criteria to be an ACTIVE staff member because his activity level was so low. She agreed this was a violation of the Medical Staff Bylaws, Rules and Regulations.
Further review of the credential files on 8/6/13 at 9:00 a.m. with MSC 3 revealed 1 (one) out of a total of eight (eight) practitioner's credential files which showed no evidence of biennial reappointment. Further investigation revealed MD 5's most recent reappointment had expired on February 28, 2013. MSC 3 produced a hospital document which corroborated this finding. She stated it had been brought to the attention of Medical Staff leadership on July 11, 2013 and they were in the process of correcting the oversight, however, it had not been corrected yet.
On 8/5/13 at 3:42 p.m., the Director of Clinical Services, Registered Nurse 1 (RN 1) was interviewed. She stated that MSC 3 reported directly to her and she was responsible for overseeing Medical Staff services. She stated she was aware of the fact that Medical staff members were routinely being reappointed without being reappraised. She stated that she had reported this directly to the Chief Executive Officer (CEO 2). She stated she had conveyed to CEO 2 the need for personnel and resources within the Medical Staff Office as a means to correct the situation.
On 8/5/13 at 4:00 p.m., Chief Executive Officer (CEO 2) was interviewed. He stated he was aware of routine reappointments of Medical Staff members without reappraisal of their competence. He stated he was the individual responsible for overseeing the entire hospital including Medical Staff services.
Tag No.: A0263
Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring that an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when:
1. The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was defined, implemented and maintained. The hospital did not provide evidence of on-going and current QAPI projects aimed at quality improvement and patient safety. (Refer to A 309)
2. The hospital failed to implement a quality control and quality improvement program based on collected data showing a compounded drug (eye drops) had two of six ingredients (gatifloxacin - an antibiotic; and flurbiprofen - reduces inflammation) as being undetected. (Refer to A 283, A 500, finding 1)
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
Tag No.: A0283
Based on observation, staff interview and document review, the hospital failed to use collected data to identify opportunities for improvement. The eye drop preparation used by the hospital for eye surgery was a compounded product of six ingredients. The hospital was aware two of the ingredients (gatifloxacin- an antibiotic; and flurbiprofen - to treat inflammantion) were undetectable in the compounded product.
The failure to implement a quality control and quality improvement program based on the data collected resulted in the potential harm of administering ineffective and potentially unsafe medications to patients.
Findings:
On 8/6/13 at 9:30 a.m., during a concurrent inspection and interview with registered nurse (RN) 1, a zip lock plastic bag containing multiple bottles (one milliliter each) of eye drops preparation was stored in the refrigerator in the preoperative (before surgery) medication storage area. Each of the one milliliter containers were identified to have an eye preparation containing six different ingredients: gatifloxacin (antibiotic), cyclopentolate (dilates pupil), flurbiprofen (reduces inflammation, and pain), lidocaine (pain relief/numbing agent), phenylephrine (dilates pupil) and tropicamide (dilates pupil). RN 1 deferred questions regarding information on the eye drop preparation to the Pharmacist (Pharm 1).
On 8/6/13 at 9:30 a.m., during an interview, Pharm 1 confirmed the hospital could not provide evidence of quality assurance data regarding the compounded eye drops. Pharm 1 stated she had no data verifying the sterility of the product; that the product was germ-free. Pharm 1 could not provide data verifying the stability of the combined ingredients and that the ingredients were compatible with each other. Pharm 1 could not provide data of the efficacy of the eye drop preparation (that the compounded eye drops were effective treatment for its intended use). Sterility and compatibility data should be obtained so that the hospital has assurance the product would give the intended effects and would not cause infections in the eye.
Pharm 1 stated information provided to the hospital about the compounded product indicated the eye drops were tested (by the compounding pharmacy) on 6/5/13 and the results confirmed and detected four out of the six components. The antibiotic (gatifloxacin) and the anti-inflammatory medication (flurbiprofen) were not detected in the preparation. Pharm 1 confirmed the hospital did not utilize this information to initiate a quality control program for the eye drop preparation.
A review article showing the stability of cyclopentolate, phenylephrine, tropicamide and lidocaine was presented by Pharm1 as evidence from the compounding pharmacy for compatibilities. The review article provided was general and was not specific to the preparation used in the hospital. It did not address the quality of the preparation in question. This preparation according to hospital staff (Admin 1) have been in use for at least a year.
During the survey, on 8/5, 8/6, and 8/8, out of 151 scheduled procedures there were 36 scheduled for cataracts surgery, which was 24% of patients treated and where the eye drops were administered. In the absence of quality assurance for the product, and only in those three days (8/5, 8/6, and 8/8), 36 patients were put at risk for infections (antibiotic not detected in the amount indicated) and at risk for inflammations, and potentially causing tissue destruction, thickening, or scarring.
No documented evidence was provided to indicate the hospital initiated a quality improvement and quality control program for the eye drops.
Tag No.: A0309
Based on staff interview and administrative document review, the hospital's governing body failed to be responsible and accountable for ensuring that an ongoing, hospital wide, date-driven Quality Assessment and Performance Improvement (QAPI) program was established when: (a) The hospital's governing body failed to ensure a QAPI program for quality improvement and patient safety was defined, implemented and maintained. (b) The hospital's governing body failed to ensure distinct improvement projects that reflected the complexity of the hospital services were conducted and documented annually. These failures resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
Findings:
On 8/5/13 at 12:16 p.m., the Chief of the Medical Staff (MD 83) and the Chief Executive Officer (CEO 2) were interviewed. MD 83 stated he was the head of the Medical Staff and he was the individual responsible for representing the Medical Staff's interactions with the hospital's leadership. CEO 2 stated he was the individual responsible for overseeing the entire hospital including Medical Staff services. They acknowledged that there was no QAPI plan in place. They stated they were aware of the failure of the hospital's leadership to ensure that Registered Nurse (RN) 1 (Director of Clinical Services) had adequate personnel and resources for a QAPI program.
On 8/5/13 at 1:30 p.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 52 "10.5 PERFORMANCE IMPROVEMENT/RISK MANAGEMENT COMMITTEE
10.5-1 COMPOSITION The Performance Improvement/Risk Management Committee shall consist of at least one representative from each clinical service, the Director of Nursing, the Infection control Nurse, Director of Quality, Lab Director, Pharmacist, representation from hospital administration and management. 10.5-2 DUTIES The duties of the Performance Improvement/Risk Management Committee shall include: (y) Recommend for approval of the Medical Executive Committee plans for maintaining quality patient care within the hospital. These may include mechanisms to: (1) establish systems to identify potential problems in patient care; (2) set priorities for action on problem correction; (3) refer priority problems for assessment and corrective action to appropriate departments of committees; (4) monitor the results of quality assessment and improvement activities throughout the hospital; and (5) Coordinate quality assessment and improvement activities. (6) Submit regular confidential reports to the Medical Executive Committee on the quality of medical care provided and on quality assessment and improvement activities conducted.
On 8/5/13 at 3:50 p.m., CEO 2 stated, "I know that we do not have a full time quality person. We tried to consolidate quality and medical staff. We got lulled into self confidence."
On 8/6/13 at 1:10 p.m., during an interview, MD 43 stated he was the Chairman of the Board of Directors. MD 43 stated he was the individual responsible for overseeing the governing body of the hospital. He acknowledged that there was no QAPI plan in place. He stated he was aware of the failure of the hospital's leadership to ensure that RN 1 had adequate personnel and resources for a QAPI program.
On 8/6/13 at 2:04 p.m., an interview was conducted with the Director of Clinical Services, Registered Nurse 1 (RN 1) who stated she was the responsible individual in charge of Quality Assessment and Performance Improvement. RN 1 verified there was no QAPI program in place and there was no documentation of quality projects. She stated there was not adequate personnel and resources for a QAPI program. She stated that she had reported this directly to the Chief Executive Officer (CEO 2). She stated she had conveyed to CEO 2 the need for personnel and resources as a means of the correcting the situation.
Tag No.: A0340
Based on staff interview and administrative document review, the medical staff failed to have a process by which the competence of medical staff members would be assessed on a periodic basis. The medical staff failed to have a process for reappraising its members when 86 out of a total of 224 medical staff members were reappointed with no evidence of periodic appraisals which considered the respective practitioners competencies. These failures placed patients at risk of receiving care from someone not qualified to provide those services.
Findings:
On 8/5/13 at 1:30 p.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 50 "10.3 MEDICAL EXECUTIVE COMMITTEE, 10.3-2 DUTIES The duties of the Medical Executive Committee shall include, but not be limited to: (h) Reviewing the qualifications, credentials, performance and professional competence, and character of applicants and staff members, and making recommendations to the Board of Directors at least quarterly regarding staff appointments and re-appointments, assignments to services, clinical privileges, and corrective action";
It indicated on page 52 "10.4 MEDICAL STAFF PROFESSIONAL PRACTICE COMMITTEE 10.4-2 DUTIES (a) The Medical Staff Professional Practice Committee will assume the Medical Staff credentialing function. The Committee will review and evaluate the qualifications of each practitioner applying for initial appointment , reappointment, or modification of clinical privileges, and, in connection therewith, obtain and consider the recommendations of the appropriate services";
On 8/5/13 at 2:00 p.m., Medical Staff Coordinator 3 (MSC 3) was interviewed. She stated Medical Staff reappointments had been made during a period which extended from November 12, 2012 thru the most recent reappointment cycle which ended April 8, 2013 without the reappointees being reappraised for competence. She stated there was no process by which, with which, or thru which Medical Staff members who had previously been granted privileges were reappraised for competence prior to being reappointed. She stated she did not have the staff or the tools to conduct substantive biennial reappraisals prior to reappointments. She stated the Director of Clinical Services, Registered Nurse 1 (RN 1) and the Chief Executive Officer (CEO 2) were aware of the fact that she did not have the staff or the tools to conduct substantive biennial reappraisals prior to reappointments .
On 8/5/13 at 3:42 p.m., the Director of Clinical Services, Registered Nurse 1 (RN 1) was interviewed. She stated that MSC 3 reported directly to her and she was responsible for overseeing Medical Staff services. She stated she was aware of the fact that Medical staff members were routinely being reappointed without being reappraised. She stated that she had reported this directly to the Chief Executive Officer (CEO 2). She stated she had conveyed to CEO 2 the need for personnel and resources within the Medical Staff Office as a means of the correcting the situation.
On 8/5/13 at 4:00 p.m., Chief Executive Officer (CEO 2) was interviewed. He stated he was aware of routine reappointments of Medical Staff members without reappraisal of their competence. He stated he was the individual responsible for overseeing the entire hospital including Medical Staff services.
Tag No.: A0353
Based on staff interviews and administrative document review; the hospital failed to verify the Medical Staff operated under the Medical Staff bylaws, rules and regulations that had been approved by the governing body when 86 Medical Staff members were not reappraised for competence prior to being reappointed, one out of eight credential files reviewed revealed one physician was not reappointed on a biennial basis and one out of eight credential files reviewed revealed a physician was granted active staff status without having met the criteria for active staff status (regularly involved in the care of twelve or more patients). These failures placed patients at a potential risk of receiving care that was not in accordance with the medical staff bylaws and medical staff rules and regulations.
Findings:
On 8/5/13 at 1:30 p.m., the hospital Medical Staff Bylaws were reviewed. It indicated on page 5 "3.2 ACTIVE STAFF 3.2-1 QUALIFICATIONS The active staff shall consist of members who: (c) Regularly admit, or otherwise are regularly involved in the care of in excess of 12-patients a year in the hospital; or are regularly involved in Medical Staff functions, as determined by the Medical staff."
It indicated on page 10 "4.4 DURATION OF APPOINTMENT AND REAPPOINTMENT" Except as otherwise provided in these Bylaws, initial appointments to the Medical Staff shall be for one year. Reappointment shall not exceed twenty-four months."
It indicated on page 50 "10.3 MEDICAL EXECUTIVE COMMITTEE, 10.3-2 DUTIES The duties of the Medical Executive Committee shall include, but not be limited to: (h) Reviewing the qualifications, credentials, performance and professional competence, and character of applicants and staff members, and making recommendations to the Board of Directors at least quarterly regarding staff appointments and re-appointments, assignments to services, clinical privileges, and corrective action";
It indicated on page 52 "10.4 MEDICAL STAFF PROFESSIONAL PRACTICE COMMITTEE 10.4-2 DUTIES (a) The Medical Staff Professional Practice Committee will assume the Medical Staff credentialing function. The Committee will review and evaluate the qualifications of each practitioner applying for initial appointment , reappointment, or modification of clinical privileges, and, in connection therewith, obtain and consider the recommendations of the appropriate services";
On 8/5/13 at 2:00 p.m., Medical Staff Coordinator 3 (MSC 3) was interviewed. She stated Medical Staff reappointments had been made during a period which extended from November 12, 2012 thru the last cycle which ended April 8, 2013 without the reappointees being reappraised for competence. She stated there was no process by which, with which or thru which Medical Staff members who had previously been granted privileges were reappraised for competence prior to being reappointed. She stated the Director of Clinical Services, Registered Nurse 1 (RN 1) and the Chief Executive Officer (CEO 2) were aware of the situation. She stated she did not have the staff or the tools to conduct substantive biennial reappraisals prior to reappointments.
On 8/6/13 at 9:00 a.m. Medical Staff credential files were reviewed with MSC 3. Review of the credential files revealed one (MD 6) out of a total of eight practitioner's credential files showed no evidence of regular admissions or regular involvement in the care of in excess of 12 patients a year in the hospital. An activity report for MD 6 revealed he had been involved in the care of only three patients during a period extending from 8/6/10 thru 8/6/13. MSC 3 stated MD 6 was on the Medical Staff and was listed in the ACTIVE staff category. She stated MD 6 did not meet the criteria to be an ACTIVE staff member because his activity level was so low. She agreed this was a violation of the Medical Staff Bylaws, Rules and Regulations.
Further review of the credential files on 8/6/13 at 9:00 a.m. with MSC 3 revealed one out of a total of eight practitioner's credential files which showed no evidence of biennial reappointment. Further investigation revealed MD 5's most recent reappointment had expired on February 28, 2013. MSC 3 produced a hospital document which corroborated this finding. She stated it had been brought to the attention of Medical Staff leadership on July 11, 2013 and they were in the process of correcting the oversight, however, it had not been corrected yet.
On 8/5/13 at 3:42 p.m., the Director of Clinical Services, Registered Nurse 1 (RN 1) was interviewed. She stated that MSC 3 reported directly to her and she was responsible for overseeing Medical Staff services. She stated she was aware of the fact that Medical staff members were routinely being reappointed without being reappraised. She stated that she had reported this directly to the Chief Executive Officer (CEO 2). She stated she had conveyed to CEO 2 the need for personnel and resources within the Medical Staff Office as a means of the correcting the situation.
On 8/5/13 at 4:00 p.m., Chief Executive Officer (CEO 2) was interviewed. He stated he was aware of routine reappointments of Medical Staff members without reappraisal of their competence. He stated he was the individual responsible for overseeing the entire hospital including Medical Staff services.
Tag No.: A0500
Based on observation, staff interviews and administrative document review, the hospital failed to ensure medications were ordered and administered in a safe and effective manner when:
1. Verification of compatibility and sterility for eye drops preparation was not provided. The eye drops were compounded and supplied by an outside pharmacy. The eye drops contained six different ingredients. The hospital did not have a program to evaluate the sterility or compatibility of the compounded eye drops.
2. Four of four registered nurses (RN 4, RN 15, RN 14, RN 13) did not demonstrate familiarity with equipment on the pediatric emergency crash cart or knowledge in operating equipment on the emergency cart.
3. Pain medication prescriptions were written for Patients 9 and 10 without directions on the frequency to administer. Nursing staff administered the medications without clarifying the orders.
4. RN 13 did not follow the hospital's protocol for pain assessment for Patient 7.
5. The Controlled Substance Flow Sheet for Patient 4 was not accurate for the medication Versed (a strong sedative also known as midazolam).
These failures resulted in the potential harm of administering medications and/or biologicals in an unsafe manner to patients, placing patients at risk for infections and/or injury.
Findings:
1. On 8/6/13 at 9:30 a.m., during a concurrent inspection and interview with registered nurse (RN) 1, a zip lock plastic bag containing multiple bottles (one milliliter each) of eye drops preparation was stored in the refrigerator in the preoperative (before surgery) medication storage area. Each of the one milliliter containers were identified to have an eye preparation containing six different ingredients: gatifloxacin (antibiotic), cyclopentolate (dilates pupil), flurbiprofen (reduces inflammation, and pain), lidocaine (pain relief/numbing agent), phenylephrine (dilates pupil) and tropicamide (dilates pupil). RN 1 deferred questions regarding information on the eye drop preparation to the Pharmacist (Pharm 1).
On 8/6/13 at 9:30 a.m., during an interview, Pharm 1 confirmed the hospital could not provide evidence verifying the compatibility of the ingredients of the compounded eye drops. Pharm 1 stated she had no data verifying the sterility of the product; that the product was germ-free. Pharm 1 could not provide data verifying the stability of the combined ingredients and that the ingredients were compatible with each other. Pharm 1 could not provide data of the efficacy of the eye drop preparation (that the compounded eye drops were effective treatment for its intended use). Sterility and compatibility data should be obtained so that the hospital has assurance the product would give the intended effects and would not cause infections and/or pain in the eye.
Pharm 1 stated information provided to the hospital about the compounded product indicated the eye drops were tested (by the compounding pharmacy) on 6/5/13 and the results confirmed and detected four out of the six components. The antibiotic (gatifloxacin) and the anti-inflammatory medication (flurbiprofen) were not detected in the preparation. Pharm 1 confirmed the hospital did not utilize this information to initiate a quality control program for the eye drop preparation and to perform in-house tests to determine safety.
A review article showing the stability of cyclopentolate, phenylephrine, tropicamide and lidocaine was presented by Pharm1 as evidence from the compounding pharmacy for compatibilities. The review article provided was general and was not specific to the preparation used in the hospital. It did not address the quality of the preparation in question. This preparation according to hospital staff (Admin 1) had been in use for at least a year.
During the survey, on 8/5, 8/6, and 8/8, out of 151 scheduled procedures there were 36 scheduled for cataracts surgery, which was 24% of patients treated and where the eye drops were administered. In the absence of quality assurance for the product, 36 patients were put at risk for infections (antibiotic not detected in the administerd eye drops) and at risk for inflammations, and potentially causing tissue destruction, thickening, or scarring.
No documented evidence was provided to indicate the hospital initiated a quality improvement and quality control program for the eye drops.
2. On 8/6/13 at 10:15 a.m., during inspection of the Preoperative area, Registered Nurse 4 (RN 4) was asked to demonstrate use of equipment and medications in the pediatric crash cart (Broselow cart). Broselow system is a commercial product designed as a tool for management of pediatric emergencies. The Broselow tape facilitates determination of medication dosages and equipment sizes for children, by measuring the child length against the tape. The cart is color-coded that matches the colors zones on the tape to serve as quick guide for identification of the appropriate supplies, and their location for fast retrieval.
a. Facility staff checks equipment and supplies daily to ensure they are available and usable. RN 4 was not sure how to check the defibrillator to make sure it was working properly. The defibrillator is a device used in emergencies to deliver electric shocks to restart the heart or correct abnormal rhythm. RN 4 had to solicit help from another nurse to perform the defibrillator check. The list to be checked daily also had batteries listed. RN 4 was asked about the batteries, but was not sure which batteries they were supposed to check. RN 4 asked another nurse, who pointed out that these were the batteries of the Laryngoscope (a device used in intubation for establishing airways.)
b. On 8/7/13 at 11:20 a.m., in the post anesthesia care unit (PACU - the area of patient care after surgery) RN 15 was asked to demonstrate what would be done during a pediatric code (an emergency situation where the heart and respirations have stopped). Presented with a hypothetical situation of a pediatric patient with weight unknown, RN 15 successfully used the Broselow tape to estimate the weight of the hypothetical patient. Referring to the (Red - Pink zone) on the tape as it indicated the length and the estimated weight for the hypothetical patient, the nurse was asked to prepare a dose of phenytoin (medication for seizure that was listed on the Broselow tape). RN 15 searched for the medication in different drawers. The nurse said that phenytoin was a seizure medication but did not consult the content list on the crash cart to see if the medication was stocked.
c. On 8/7/13 at approximately 12 p.m., in the PACU, RN 14 was asked to demonstrate the steps to take during a pediatric code. RN 14 successfully used the tape and found the medication requested. However, when asked the air bag (self-reinflating bag used during resuscitation), the nurse had difficulties assembling the bag to demonstrate its use. RN 14 had to open another bag, which also took some time to assemble. When RN 14 asked about the process of checking the defibrillator, the nurse said that the person that opened the unit is responsible for performing the daily checks and that she was not that familiar with it.
d. RN 14 opened a binder on the top of the cart that had the "Post Anesthesia Care Unite Crash Cart Check List." The list had items to be checked including defibrillator, Oxygen tank, suction, and other supplies. On 8/7/13, the signature for the person performing these tasks was for RN 13 who was interviewed. RN 13 was asked to check the defibrillator. She did and pointed out that because the device had a self-check function, pointing to the check mark displayed indicating that the device is in a working condition, the actual check needs to be done only once per week.
The instruction on the top of the, Post Anesthesia Care Unit Crash Cart Check List, sheet had instructions to "check every 24 hours when department is open."
On 8/7/13 at 2:20 pm, during an interview, RN 2 (nurse manager), confirmed the defibrillator was supposed to be checked daily. The facility policy titled, Crash Cart Checks, approved on 6/28/12 was reviewed. Under procedure for department responsibilities, the policy directed to perform a defibrillator check every shift. RN 2 clarified that the facility had only one shift within 24 hours.
3. a. On 8/8/13 at 8:45 am, the record for Patient 9 was reviewed with RN 11. The Post Anesthesia Care Unit (PACU) preprinted order set had four different options of oral medications for pain control. The order set allowed for selection of any of the medications in various doses, but the order set did not specify the frequencies of how often these doses to be given.
Patient 9 had an order for Norco 7.5 mg (a combination of 7.5 mg hydrocodone, opiate type medication, and acetaminophen 325mg known as Tylenol). Hydrocodone 7.5 mg was supposed to be given for moderate pain. However, there was no indication of how often to give this medication. Similarly, the patient had an order for Percocet (also a combination of Oxycodone and acetaminophen). The order directed to give 7.5 mg of Oxycodone for mild pain, 10 mg for moderate pain, and 20 for severe pain. There were no directions on how frequently to administer the medication. In addition, there was no documented evidence of clarifying these orders by nursing or pharmacy staff.
3. b. On 8/8/13 at 9:30 am, the record for Patient 10 was reviewed with RN 11. The record revealed that Patient 10 was ordered oral medications for post-surgical pain. The orders included Norco and Percocet. Norco is a combination of varying strength of hydrocodone, opiate type medication, and acetaminophen 325 mg known as Tylenol. Percocet is also a combination of varying strength of Oxycodone and acetaminophen 325 mg. Both medications were ordered to be given at 5, 10 and 20 milligrams for mild, moderate, or severe pain, respectively. None of the orders had the frequency at which these medications were to be administered.
Hydrocodone is less potent than oxycodone; therefore, these medications are not interchangeable. A 20-30 milligrams dose of oxycodone may equal 30-45 mg of hydrocodone. Oxycodone is essentially 1.5 to 2 times stronger than hydrocodone. The order did not specify which of the medications, Norco or Percocet, to be given at what circumstances, and there was no documented evidence that nursing or pharmacy staff clarified these orders.
RN 11 did not provide a rationale as to the reason nursing did not clarify the orders for pain medications prior to administration.
4. On 8/7/13 at 9:30 a.m., in the PACU, the medical record for Patient 7 was reviewed. Patient 7 was ordered meperidine 25 milligrams for moderate pain every 5 minutes. The record showed that Patient 7 was administered four doses of meperidine on 8/6/13 at 1:30 p.m., 1:35 p.m., 1:45 p.m., and 1:50 p.m. Review of the Nurse's Notes for that time revealed documentation of pain scale 9 out of 10 at 1:30 p.m. and severe pain (no scale) at 1:45 p.m. There was no documented evidence of pain assessment for the other two doses at 1:35 p.m. and 1:50 p.m.
On 8/7/13, at 10 a.m., RN 13 who was taking care of Patient 7 was interviewed. The nurse did not provide justification for not evaluating the pain for Patient 7 before each of the doses or the effectiveness of the medication given.
Review of the facility's policy titled "Pain Management" approved on 6/28/12 revealed under responsibilities of the caregiver the following:
"Assess and document pain systemically a. location (s), b. intensity (0-10) ...Assess and document the patient's attitude/ perceptions and values regarding his/her pain ...Document ... effectiveness of analgesic regiment and other interventions."
5. On 8/6/13 at 1:30 p.m., the medical record for Patient 4 was reviewed. The Controlled Substance Flow Sheet the facility used to track controlled substance showed 20 milligrams (mgs) of Versed (a sedative medication, also known as midazolam) were administered on 8/5/13. The amount of used and wasted (on 8/5/13) totaled 9 milligrams, and the amount returned to the box was 10 mgs. That left one milligram of versed not accounted for. On 8/6/13 at approximately 5 pm, the discrepancy was shared with a facility staff (Admin 1), who did not have an explanation for the discrepancy. On 8/7/13 at 9:30 am, during an interview with MD 1, he said he must have wasted 2 milligrams instead of 1 mg.