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Based on observations, review of clinical records, policies and procedures, Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, quality improvement documentation, personnel records and interviews, it was determined the facility to develop and monitor quality indicators for all patient care departments, failed to incorporate the monitoring of restraints into the Quality Assurance/Performance Improvment per facility policy, failed to ensure preventive maintenance was performed on one of one portable x-ray machine, failed to provide corrective action for quality monitoring of films taken by the portable x-ray machine, and failed to ensure there was qualified physician oversight of the Radiology Department.
The failed practices had the potential to affect patient health and safety in the delivery of care related to the lack of a Quality Assurance/Peformance Improvement process, the portable x-ray machine not functioning to produce quality films and no qualified physician to oversee the Radiology Department. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:

A. Based on review of Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, Policy and Procedure CS1-10 Restraints, 3 of 3 active clinical records of patients in restraints and interview with the Director of Clinical Services, it was determined the facility failed to monitor the use of restraints per the Quality Assurance/Performance Improvement Program, failed to develop quality indicators for all patient care departments, and failed to monitor all patient care departments to identify potential problems. See A267 and A285 for details.
B. Based on review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, 3 of 3 active clinical records of patients in restraints and interview with the Director of Clinical Services it was determined the facility failed to monitor the use of restraints. See A 285 for details.
C. Based on Radiology Policy review, cardiopulmonary resuscitation (CPR) certification review, quality improvement monitoring review and interview, it was determined the facility failed to ensure diagnostic radiological services met the needs of the patients related to failure to provide preventive maintenance for radiology equipment; failure to ensure current CPR certification for five of five Radiology Technologists; failure to designate a radiology qualified physician to supervise the radiology department; and failure to integrate the Radiology Department into the hospital-wide quality assessment/performance improvement (QAPI) program See A 528 for details.

Based on review of Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, Policy and Procedure CS1-10 Restraints, 3 of 3 active clinical records of patients in restraints and interview with the Director of Clinical Services, it was determined the facility failed to monitor the use of restraints per the Quality Assurance/Performance Improvement Program, failed to develop quality indicators for all patient care departments and failed to provide actions plans when indicators were not met or revise the plan when threshholds were consistently not met. The failure to have an ongoing Quality Assurance/Performance Improvement progam had the potential to affect the health and safety of patients in the delivery of care and to identify patients that were being placed in restraints with no physician orders and no evidence of least restrictive measures being attempted. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:

A. Based on review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, 3 of 3 active clinical records of patients in restraints and interview with the Director of Clinical Services it was determined the facility did not collect data and analyze the use of restraints per facility policy. See A285 for details.
B. Based on review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007 and interview with the Director of Clinical Services, it was determined the facility did not develop quality indicators for all patient care departments to collect and analyze data to identify potential problems. See A267 for details.
C. Review of Policy and Procedure CS1-10 Restraints, page 3, revealed restraint usuage would be reported to the Quality Assurance/Performance Improvement Commitee.
D. Findings were confirmed in interview with the Director of Clinical Services at 1515 on 11/16/10.

Based on Radiology Policy review, cardiopulmonary resuscitation (CPR) certification review, quality improvement monitoring review and interview, it was determined the facility failed to ensure diagnostic radiological services met the needs of the patients related to failure to provide preventive maintenance for radiology equipment; failed to ensure current CPR certification for five of five (#1-#5) Radiology Technologists; failed to designate a radiology qualified physician to supervise the radiology department; and failed to integrate the Radiology Department into the hospital-wide quality assessment/performance improvement (QAPI) program. The failed practice had the potential to affect the safety of all patients receiving x-rays in the facility. Failure to ensure preventive maintenance and provide corrective action for quality monitoring of films taken by the portable x-ray machine had the potential to affect patient safety related to poor diagnostic film results. The lack of qualified physician oversight and lack of current CPR trained Radiology Technologists had the potential to affect the safety of patients related to medical issues and emergency situations. Evidence follows:

A. The facility failed to perform preventive maintenance on the only x-ray machine it had (a portable x-ray machine). See A 537 for details.
B. The facility failed to ensure current CPR certification for five of five Radiologic Technologists. See A 545 for details.
C. The facility failed to designate a qualified physician to supervise the radiological services. See A 546 for details.
D. The facility failed to integrate the Radiology Department into the hospital-wide QAPI program as follows:
1) Review of the Radiology quality improvement monitoring from November 2009 through October 2010 revealed the department monitored film reject analysis for 12 consecutive months. They never met their established threshold of less than 10% reject films and never documented a corrective action.
2) Interview with the Radiology Supervisor at 1020 on 11/16/10 revealed the portable x-ray machine was old and it was difficult to position the type of patients they had in the facility to obtain good results.
3) Negative Dictation Analysis was monitored July through October 2010. The threshold of 10% was exceeded three of the four months with no corrective action.
4) The Radiology Supervisor confirmed the lack of corrective action to report to the hospital-wide Quality Assessment Performance Improvement Committee during interview at 1620 on 11/16/10.

Based on review of three of three active clinical records, one closed clinical record of patients in restraints and interview with the Director of Clinical Services, it was determined the facility failed to document the type of restraint used when the patient was restrained and the behavior that necessitated the use of restraints on the patients' plan of care The failed practice had the potential for patients to be placed in restraints before alternative measures could be attempted and failure to document the use of restraints on the plan of care could result in staff not assuring continuity of care. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:
A. Review of active Clinical Record #8 revealed there was no evidence of the type of restraint used, the dates the patient was restrained and reason for restraints documented on the Interdisciplinary Plan of Care.
B. Review of active Clinical Record #12 revealed there was no evidence of the type of restraint used, the dates the patient was restrained and reason for restraints documented on the Interdisciplinary Plan of Care.
C. Review of active clinical Record #15 revealed there was no evidence of the type of restraint used, the dates the patient was restrained and reason for restraints documented on the Interdisciplinary Plan of Care.
D. Review of closed Clinical Record #29 revealed there was no evidence of the type of restraint used, the dates the patient was restrained and reason for restraints documented on the Interdisciplinary Plan of Care.
E. Findings were confirmed in interview with the Director of Clinical Services at 1140 on 11/18/10 for Clinical Records #8,#12,#15, and #29.

Based on review of three of three active clinical records of patients in restraints, one closed clinical record of patients in restraints, Policy and Procedure Restraints No. CS1-10, and interview with the Director of Clinical Services, it was determined the facility failed to get a signed physicians' order for each episode restraints were used. The failed practice resulted in patients not being evaluated by a physician or registered nurse to determine the type of restraint needed before restraints were applied. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:
A. Review of Policy and Procedure Restraints No. CS1-10 page 4, revealed orders for restraints would be issued by a member of the active medical staff. Orders could not exceed 24 hours. Orders must state the date and time of entry for the order, the justification for restraint, the type of restraint; and the time limit for the restraint. Page 2 of the Policy and Procedure Restraints No. CS1-10 stated restraint devices were limited to soft limb restraint, vest restraint, and mittens.
B. Review of active Clinical Record #08 revealed nursing notes dated 10/27/10 at 0800 stated the patient' s left wrist was restrained. A nursing note dated 10/27/10 at 2000 stated bilateral wrist restraints were in place. There was no evidence of a signed physician order for wrist restraints on 10/27/10. A nursing noted dated 10/29/10 at 2400 stated side rails were up times 4. There was no evidence of a signed physician order for side rails up times 4 on 10/29/10. A nursing note dated 10/31/10 at 2200 stated the "restraints loosened, not off, not taut". There was no evidence of a signed physician order for restraints on 10/31/10. A nursing note dated 11/03/10 at 2000 stated the patient was in bilateral wrist restraints. There was no evidence of a signed physician order for bilateral wrist restraints on 11/03/10. A nursing note dated 11/04/10 at 2015 stated bilateral wrist restraints were in place to prevent the patient from pulling lines and tubes. There was no evidence of a signed physician order for bilateral wrist restraints on 11/04/10.
C. Review of active Clinical Record #12 revealed a physician order for wrist restraints dated 11/17/10 at 0700 was not signed by the physician at 1400 on 11/18/10.
D. Review of active Clinical Record #15 revealed nursing notes dated 11/11/10 at 2400 stated side rails were up times 4 and the patient was in bilateral wrist restraints. Nursing notes dated 11/12/10 at 0500 stated side rails were up times 4. Nursing notes dated 11/13/10 at 0400 stated the patient was in bilateral soft wrist restraints. There were no signed physician orders for side rails up times 4 on 11/11/10 and 11/12/10. There was not a signed physician order for bilateral soft wrist restraints on 11/13/10.
E. Review of Clinical Record #29 revealed nursing notes dated 08/20/10 at 0200 stated the patient was attempting to pull out a catheter and get out of bed. A physician' s order was timed at 0200 and signed by the physician but did not have a date. A nursing note dated 08/21/10 at 0400 stated the patient was in bilateral wrist restraints. There was not a physicians order for the bilateral wrist restraints used on 08/21/10.
F. Interview with the Director of Clinical Services at 1132 on 11/18/10 confirmed the findings for Clinical Records #8, #12, #15, and #29.

Based on review of the Patient Weights Policy, review of clinical records and interview, it was determined the Registered Nurse (RN) failed to evaluate the patient's needs to be weighed according to physician order and facility policy for 6 (#1, #3, #4, #5, #10 and #11) of 16 (#1 through #16) current patients. The failed practice had the potential to affect all patients in the facility whose nutritional and medical needs could not be accurately assessed without monitoring weights. Evidence follows:

A. Review of the Patient Weights Policy, revised 11/2007, revealed all patients were weighed on admission, per physician order, or could be initiated by an RN based on assessment data. Patient weights were to be documented in the clinical record and were to be tracked with any unusual findings reported to the physician.
B. Review of the clinical record for Patient #1 revealed the following:
1) An order written on 10/23/10 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 10 of 27 days from 10/23 through 11/17/10.
3) The lack of daily weights was confirmed by the Director of Clinical Services (DCS) at 1035 on 11/18/10.
C. Review of the clinical record for Patient #3 revealed the following:
1) Patient #3 was not weighed on admission to the facility per facility policy.
2) The failure to weigh the patient on admission was confirmed by the DCS at 1100 on 11/18/10.
D. Review of the clinical record for Patient #4 revealed the following:
1) An order written on 11/01/10 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 7 of 18 days from 11/01 through 11/17/10.
3) The lack of daily weights was confirmed by the Director of Clinical Services (DCS) at 1046 on 11/18/10.
E. Review of the clinical record for Patient #5 revealed the following:
1) An order written on 10/20/10 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 7 of 29 days from 10/20 through 11/17/10.
3) The lack of daily weights was confirmed by the Director of Clinical Services (DCS) at 1430 on 11/18/10.
F. Review of the clinical record for Patient #10 revealed the following:
1) An order written on 10/14/10 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 6 of 33 days from 10/14 through 11/15/10.
3) The lack of daily weights was confirmed by the Director of Clinical Services (DCS) at 1120 on 11/18/10.
G. Review of the clinical record for Patient #11 revealed the following:
1) An order written on 10/14/10 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 6 of 15 days from 11/03 through 11/17/10.
3) The lack of daily weights was confirmed by the Director of Clinical Services (DCS) at 1043 on 11/18/10.
H. Review of the clinical record for Patient #11 revealed the following:
1) An order written on 11/03/09 for daily weights.
2) Review of the Graphic Sheets revealed the daily weights were not performed for 6 of 15 days from 11/03 through 11/17/10.


29485

Based on clinical record review, policy and procedure review, and interview, it was determined the Registered Nurse failed to supervise and evaluate each patient's care in that 6 of 16 active clinical records ( #2, #4, #7, #10, #11, and #15) and 1 of 13 closed records (#20) lacked documentation the patient was offered personal hygiene assistance/care daily and as necessary as required by policy and procedure number CS3B-37. Failure to offer daily and as needed personal hygiene assistance/care had the potential outcome of poor hygiene and the inability to identify and prevent potential skin breakdown as required by facility policy and procedure. The failed practice had the potential to affect all 16 current patients. Findings follow:
A. Review of Patient #2's clinical record on 11/18/10 revealed no evidence of personal hygiene assistance/care was offered, performed or refused on 11/12/10, 11/13/10, 11/14/10 and 11/16/10.
B. Review of Patient #4's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered, performed or refused on 11/11/10 and 11/12/10.
C. Review of Patient #7's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered, performed or refused on 11/12/10 and 11/15/10.
D. Review of Patient #10's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered, performed or refused on 10/15/10, 10/16/10, 10/20/10, 10/22/10, 10/26/10 through 11/2/10, 11/11/10, 11/13/10 and 11/14/10.
E. Review of Patient #11's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered, performed or refused on 11/10/10 and 11/14/10.
F. Review of Patient #15's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered performed or refused 11/10/10 and 11/15/10 through 11/17/10.
G. Review of Patient #20's clinical record on 11/18/10 revealed no evidence personal hygiene assistance/care was offered, performed or refused from 9/10/10 through 9/26/10 and 9/28/10 through 10/4/10.
H. Review of facility policy and procedure number CS3B-37 reveals patients shall be offered personal hygiene assistance/care on a daily basis and as necessary.
I. During an interview with the Director of Clinical Services at 1420 on 11/18/10, she confirmed the above findings.

Based on review of clinical records, policies and procedures, staff interview and review of 9 of 16 active records (#1, #2, #3, #7, #10, #11, #12, #13, and #14) and 5 of 13 closed records (#21, #22, #24, #25 and #26), it was revealed Schedule II through V medications were administered after the five day stop date. The medication stop date is the date the medication automatically stops unless the practitioner continues the order. The outcome of administering Schedule II-V medications after the stop date could result in depressed respiratory status, decreased level of consciousness, increased risk of falls, increased risk of immobility and dependency. The failed practice had the potential to affect all patients receiving Schedule II- V medications who were admitted to the facility. The findings follow:

A. Review of Patient #1's Medication Administration Record (MAR) on 11/17/10 revealed Percocet 5 milligram (mg)/Acetaminophen 325 mg ordered on 10/23/10 and a stop date of 10/29/10 was administered on 11/03/10, 11/04/10, and 11/05/10.
B. Review of Patient #2's MAR on 11/17/10 revealed Percocet 5 mg/Acetaminophen 325 mg ordered on 11/10/10 and a stop date of 11/15/10 was administered on 11/16/10.
C. Review of Patient #3's MAR on 11/17/10 revealed Morphine 2 mg IVP (Intravenous Push) ordered on 10/27/10 and a stop date of 11/1/10 was administered on 11/02/10, 11/03/10, 110/4/10 and 11/05/10; Xanax 0.5 mg ordered on 10/27/10 and a stop date of 11/01/10 was administered on 11/08/10 and 11/09/10. The progress notes dated 11/06/10 contained physician documentation of the daughter's concerns the patient was being over-sedated and respiratory suppressed.
D. Review of Patient #7's MAR on 11/17/10 revealed Morphine Immediate Release 15 mg ordered on 11/3/10 and a stop date of 11/06/10 was administered on 11/09/10, 11/10/10, and 11/11/10.
E. Review of Patient #10's MAR on 11/17/10 revealed Morphine 5 mg IVP ordered on 10/15/10 and a stop date of 10/20/10 was administered 10/21/10, 10/23/10, 10/24/10, 10/25/10, 10/26/10, 10/27/10, 10/28/10, 10/30/10, 10/31/10, 11/08/10, and 11/09/10; Percocet 5 mg/325 mg 1-2 tablets by mouth every four hours as needed for pain ordered on 10/14/10 and a stop date of 10/20/10 was administered on 10/22/10,10/25/10, 10/26/10, 10/27/10, 10/29/10, 10/30/10, 10/31/10, 11/01/10, 11/02/10, 11/03/10, 11/04/10, 11/05/10, 11/06/10, 11/07/10, 11/08/10, 11/09/10, 11/10/10, 11/11/10, 11/12/10, and 11/14/10; Ambien 5 mg by mouth at bedtime as needed for insomnia ordered on 10/14/10 and a stop date of 10/20/10 was administered on 10/23/10, 10/29/10, 10/30/10, 10/31/10, 11/01/10, 11/03/10, 11/04/10, 11/05/10, 11/06/10, 11/07/10, 11/09/10, 11/10/10, 11/11/10, 11/12/10 and 11/14/10.
F. Review of Patient #11's MAR on 11/17/10 revealed Hydrocodone 7.5 mg/ Acetaminophen 325 mg ordered on 11/03/10 and a stop date of 11/08/10 was administered on 11/12/10, 11/13/10, and 11/14/10; Ambien 5 mg ordered on 11/03/10 and a stop date of 11/08/10 was administered 11/12/10, 11/13/10, and 11/14/10.
G. Review of Patient #12's MAR on 11/17/10 revealed Hydrocodone 7.5 mg/ Acetaminophen 325 mg ordered 10/20/10 and a stop date of 10/25/10 was administered on 11/11/10, 11/12/10, 11/13/10 and 11/14/10.
H. Review of Patient #13's MAR on 11/17/10 revealed Hydrocodone 5 mg/Acetaminophen 325 mg ordered on 11/4/10 and a stop date of 11/9/10 was administered on 11/10/10, 11/11/10, 11/12/10, 11/13/10, 11/14/10 and 11/15/10.
I. Review of Patient #14's MAR on 11/17/10 revealed Hydrocodone 5 mg/Acetaminophen 500 mg ordered 11/10/10 and a stop date of 11/15/10 was administered on 11/18/10.
J. Review of Patient #22's MAR on 11/17/10 revealed Demerol 25 mg IVP every 6 hours as needed for pain ordered on 10/01/10 and a stop date of 10/05/10 was administered on 10/14/10 and 10/15/10.
K. Review of Patient #24's MAR on 11/17/10 revealed Hydrocodone 7.5 mg/Acetaminophen 500 mg ordered 08/13/10 and a stop date of 08/18/10 was administered on 09/08/10, 09/09/10, 09/11/10, 09/12/10, 09/13/10, 09/17/10, 09/21/10, 09/22/10, 09/23/10, 09/24/10, 09/25/10, 09/26/10, 09/27/10 and 09/28/1; Ambien 5 mg ordered on 08/13/10 and a stop date of 08/18/10 was administered on 09/08/10, 09/09/10, 09/23/10, 09/24/10, 09/25/10, 09/26/10 and 09/27/10.
L. Review of Patient #25's MAR on 11/17/10 revealed Hydrocodone 7.5 mg /Acetaminophen 325 mg ordered 09/30/10 and a stop date of 10/05/10 was administered on 10/07/10, 10/08/10, 10/10/10, 10/12/10, 10/14/10, 10/16/10, 10/17/10, 10/18/10, 10/20/10, 10/21/10, 10/22/10, 10/23/10, 10/24/10, 10/25/10, 10/26/10, 10/27/10 and 10/28/10.
M. Review of Patient #26's MAR on 11/17/10 revealed Fentanyl 50 mg IVP every 1 - 2 hours as needed for pain ordered 08/17/10 and a stop date of 08/22/10 was administered on 10/03/10; Lorcet 7.5 mg/Acetaminophen 500 mg ordered on 08/17/10 and a stop date of 08/22/10 was administered on 10/17/10.
N. Facility policy and procedure number PCS-05-05 stated the Automatic Stop Order policy applies to the following drugs and drug classes: Controlled Drugs (Schedule II-V) - 5 days. Policy number PCS-05-05 also stated nursing should notify the responsible practitioner (24 hours when possible) before the impending expiration of an order to re-order the medication.
O. Findings confirmed by the Director of Clinical Services on 11/18/10 at 1120 and again at 1450.

Based on observation and interview, the Director of Pharmacy failed to check/supervise the placing of all medications in medication cassettes by a Pharmacy Technician prior to dispensing the medications for administration to patients on one of a total of one nursing units. The potential existed for the current patient census of 16 and the average daily census of 18 patients to receive incorrect medications which would affect patient safety. Findings follow:

A. On 11/16/10 at 1045, the Pharmacy Technician was observed placing medications in medication cassettes for dispensing to the facility's sixteen patients at the one nursing unit. The Director of Pharmacy was not observed supervising by checking medications placed in patient cassettes by the Pharmacy Technician.
B. An interview was conducted with the Director of Pharmacy on 11/16/10 at 1100. The Director of Pharmacy stated only a few of the medication cassettes filled with patient medications by the Pharmacy Technician were checked for accuracy prior to dispensing of the medications. It was stated this had been a past and current practice in the Pharmacy.

Based on observation and interview, the facility failed to ensure outdated medications were not available for patient use at two (Nursing Unit, Pharmacy) of a total of two medication storage areas. The potential existed for the current census of 16 patients and the average daily census of 18 patients to receive outdated medications that would affect patient safety. Findings follow:

A. A tour of the Nursing Unit was conducted on 11/15/10 between 0900 and 1045. The following outdated medications were observed available for patient use:
1) Fourteen vials of Enalaprilal 1.25milligrams(mg)/milliliter(ml) expired 09/01/10;
2) Three vials of Enalaprilal 1.25mg/ml expired 04/01/10;
3) Eight Metoclopramide Oral Suspension 10mg/10ml expired 10/31/10;
4) Two Valproic Acid Syrup 250mg/5ml expired 10/31/10;
5) One ampule Naloxone 0.4mg/ml expired 02/01/10;
6) Two vials Norepinephrine 4mg/4ml expired 08/10;
7) Two vials Norepinephrine 4mg/4ml expired 09/10;
8) Ten Prevalite Powder 4 grams(gm) expired 09/10;
9) Thirteen Diphenhydramine Elixir 5ml expired 10/10;
10) Seven Amitriptylene HCL 25mg tablets expired 07/10;
11) Twenty Enalapril Maleate 20mg tablets expired 06/10;
12) Fourteen Folic Acid 1mg tablets expired 02/09;
13) Eight Senna-S tablets expired 11/09;
14) Nine Sertraline 50mg tblets expired 06/10;
15) Two Sertraline 50mg tablets expired 08/10;
16) Five Trazodone HCL 50mg tablets expired 07/01/09;
17) Eleven Sorbitol Solution 70% 30ml expired 10/10;
18) One Lactated Ringers Intravenous Solution 1000ml expired 03/10;
19) Six vials Mannitol 25% 50ml expired 10/01/10;
20) Two vials Mannitol 25% 50ml expired 06/01/09;
21) One vial Mannitol 25% 50ml expired 08/01/09;
22) Twelve vials Butorphanol 1mg/ml expired 08/01/10; and
23) Thirty-nine Tylenol #3 tablets expired 10/10.
B. A tour of the Pharmacy was conducted on 11/16/10 at 0925. Thirty-five Diphenhydramine Elixir 5ml were observed to be outdated 10/10 and available for patient use.
C. An interview was conducted with the Director of Pharmacy on 11/15/10 at 1100 in which it was verified the medications at the Nursing Unit were outdated. An interview was conducted with the Director of Pharmacy on 11/16/10 at 0930 in which the outdated medications in the Pharmacy were verified.


Based on observation, review of Pharmacy Policy PCS-06-03, and interview, the facility failed to ensure proper labeling of vials of medications in that the labels lacked lot numbers required for manufacturer drug recalls. The omission of lot numbers in labeling affected 9 (#1, #5, #10, #11,#12, #13, #14, #15, #16) of 16 (#1-#16) current patients and the potential to affect the average daily patient census of eighteen. Patients had the potential to receive medications that had been recalled by manufacturers which would affect patient safety. Findings follow:

A. Pharmacy Policy PCS-06-03 was reviewed on 11/15/10 at 1520. The policy reflected all labels on dispensed medications would reflect lot numbers.
B. Medications dispensed to the hospital census of sixteen were observed on 11/15/10 between 1020 and 1045. Labels refllected nine of sixteen patients had medications dispensed for administration without lot numbers. Following are medications dispensed to patients in medication vials in which the labels lacked lot numbers:
1) Patient #1-Aspirin 325 milligrams(mg) Enteric Coated;
2) Patient #5-Diltiazem 120mg CR;
3) Patient #10-Isosorbide Mononitrate 30mg;
4) Patinet #11-Topiramate 25mg;
5) Patient #12-Neurontin 100mg;
6) Patient #13-Nabumetone 500mg;
7) Patient #14-Zince Sulfate 220mg;
8) Patient #15-Guaifenesin SA; and
9) Patient #16-Azithromycin 250mg.
C. The Director of Pharmacy was interviewed on 11/16/10 at 0900 and verified that lot numbers were not put on labels of medication dispensed in medication vials.

Based on interviews and review of policies and procedures, it was determined the facility failed to ensure a plan was in place for preventive maintenance of the x-ray equipment (one portable x-ray machine). The failed practice had the potential to affect patient safety for all patients who received x-rays in that it could not be assured the x-ray equipment was in safe working condition. Evidence follows:

A. Review of Radiology Policies and Procedures revealed the lack of a plan to provide preventive maintenance per manufacturer's recommendations for the x-ray equipment
B. Preventive maintenance documentation for the radiology equipment was not produced during the survey.
C. The Radiology Supervisor stated during interview at 1020 on 11/16/10 preventive maintenance was not performed on the machine.

Based on interview, it was determined the Radiology Department lacked supervision by a physician director who was qualified by education or experience in radiology. The failed practice had the potential to affect the safety of all patients receiving x-rays due to lack of oversight for the medical aspects of radiology. Evidence follows:

A. The facility failed to provide evidence a physician qualified by education or experience in radiology was designated to supervise the radiology department.
B. Interview with the Radiology Supervisor at 1030 on 11/16/10 revealed the facility changed consulting radiology groups in October 2010, and he did not know yet who the physician supervisor was.

Based on observation, review of Dietary Policies and Procedures, the therapeutic diet manual, quality improvement documentation and interviews, it was determined the facility failed to ensure the Dietary organizational requirements were met related to the availability of a current therapeutic diet manual and integration of the Dietary service into the hospital-wide Quality Assurance Performance Improvement (QAPI) program. The failed practice had the potential to affect the safety of all patients admitted to the facility related to the failure to monitor problem areas and the potential for patients to receive incorrect meals, snacks, supplements, enteral or parenteral nutrition without a ready reference for current practice. Evidence follows:

A. The therapeutic diet manual was the sixth Edition of the Manual of Clinical Dietetics with a copyright date of 2000.
1) The copyright date was greater than five years old, and no updates or revisions were provided.
2) A copy of the therapeutic diet manual was not available to the nursing and physician staff. At 1330 on 11/15/10, the manual was requested at the nurse's station. It could not be found, none of the nurses knew what it looked like and Case Manager #1 stated, "I've been here forever, and I've never seen one."
3) The above was confirmed by the Dietary Director during interview at 1020 on 11/15/10. She was only aware of one copy, which was kept in her office.

B. Review of Dietary QAPI for October 2009 through October 2010 revealed the following:
1) The facility monitored five indicators and correct food temperature during that time period.
2) Four (correct diet; correct diet order; trayline times; and refrigerator log documentation) of five areas monitored exceeded established thresholds of 80% every month for thirteen months with no corrective action needed, indicating quality monitoring rather than quality improvement.
3) The fifth monitor (correct food temperature) was monitored in March, April and July 2010. The results for March exceeded the 80% threshold. The results for April were below threshold at 75%. The results for July were above threshold at 95%. The same corrective action was documented for April when results were below threshold and for July when results were well above threshold. There was no other evidence correct food temperature was monitored or that any problem areas were monitored from July through October 2010.
4) Failure of the Dietary Department to monitor problem areas for quality improvement and to report results to the Quality Assurance/Performance Improvement Committee was confirmed by the Dietary Director at 1550 on 11/15/10.

Based on observation, review of the therapeutic diet manual and interview, it was determined a therapeutic diet manual approved by the medical staff and dietitian, with not more than five years since the publication/revision date was not readily available to physicians, nurses and dietary staff. The failed practice had the potential to affect patient safety for all patients admitted to the facility. The lack of an approved, current therapeutic diet manual created the potential for patients to receive incorrect meals, snacks, supplements, enteral or parenteral nutrition without a ready reference for current practice. Evidence follows:
A. The therapeutic diet manual used by the facility was the sixth Edition of the Manual of Clinical Dietetics. The manual had a copyright date of 2000, and no updates or revisions were provided.
B.
C. A copy of the therapeutic diet manual was not available to the nursing and physician staff. At 1330 on 11/15/10, the manual was requested at the nurse's station. It could not be found, none of the nurses knew what it looked like and Case Manager (#1) stated, "I've been here forever, and I've never seen one."
D. The above was confirmed by the Dietary Director during interview at 1020 on 11/15/10. She was only aware of one copy, which was kept in her office.

Based on review of 16 active clinical records, 13 closed clinical records, Policy and Procedure CS5-3 Discharge Planning, and interviews with the Director of Clinical Services and Discharge Planner #1, it was determined the facility failed to initiate an interdisciplinary discharge plan for each patient on admission per facility policy and procedure for 8 of 29 patients. The failed practice prevented the patient's discharge plans from being implemented to assure post discharge needs were met. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:
A. Review of Policy and Procedure CS5-3 Discharge Planning revealed an interdisciplinary discharge plan would be initiated on admission for each patient.
B. Five (#1,#3,#5,#8,#14) of sixteen active clinical records did not contain evidence discharge planning was initiated on admission.
C. Three of thirteen (#21,#27,#18) closed clinical records did not contain evidence discharge planning was initiated on admission.
D. Interview with Discharge Planner #1 at 0920 on 11/17/10 revealed discharge planning was conducted weekly during team conference meetings. In addition, she stated she did not know if discharge planning was initiated on admission or where it would be documented.
E. Interview with the Director of Clinical Services at 1225 on 11/17/10 revealed discharge planning activities were documented on page #4 Social Services/Case Management portion of the Interdisciplinary Admission Assessment form. During the interview, she confirmed there was no evidence of discharge planning being initiated on admission per facility policy. In addition, she stated discharge planning was not discussed until the weekly team conference meeting.

Based on clinical record review, policy and procedure review and interview, it was determined the facility failed to follow their policies that required respiratory services be provided based on physician's orders for care and failed to have a current policy and process in place to address routine orders for Respiratory Protocol for 8 (#1-5,8,9,14,) of 16 (#1-16) in-patients who received Respiratory therapy. The failure to have a physician order for medication, treatments, and ABG's (Arterial Blood Gases) placed patients at potential risk of injury due to lack of intervention by a physician licensed to prescribe and practice medicine. The failed practice affected the eight patients on the census who were receiving respiratory services and had the potential to affect the other eight patients who were admitted to the unit. Findings follow:
A. Patient #1 was admitted to the facility 10/23/10 with a diagnosis of Respiratory Failure and Malnutrition. Admission orders included "Albuterol 0.083% INH solution PRN (as needed) Q (every) 2 hours, Atrovent 0.02 INH solution QID (four times per day)." Page two of the physician admission orders under consults had checked "Respiratory evaluation and respiratory protocol." On 10/25/10 at 0750 the Physician's order sheet listed "Respiratory orders: O2 (oxygen) (check marked) BID (two times per day) maintain SPO2 > (greater than or equal to) 93%, (change symbol) Albuterol/Atrovent TID (three times per day) & PRN, Assessment Q day" The order was signed by (initials) Respiratory Therapist. An entry dated 10/30/10 at 1112 stated "Respiratory Orders: D/C (discontinue) Albuterol/Atrovent-TID and PRN, Start Albuterol/Atrovent - BID and PRN, O2-Keep SpO2 > (greater than) 90% wean as tolerated, RT (Respiratory Therapist) assessment daily" and signed by (named) Respiratory Therapist. The entry did not reference a physician who provided the order or if it was a verbal or telephone order." The findings were confirmed by the Director of Clinical Services on 11/18/10 at 1035.
B. Patient #2 was admitted to the facility 11/10/10 with a diagnosis of Respiratory Failure, Pneumonia, status post Motor Vehicle Accident, paraplegic. Admission orders included "Respiratory evaluation and respiratory protocol - CPT (Chest Percussion Therapy). " Other written orders included "Continuous BiPAP (Bilevel Positive Airway Pressure) 40% FiO2 (Fractional Inspired Oxygen)" "RT to manage". An entry 11/10/10 stated "Clarification of Respiratory orders: Daily RT Assessment, 02 and BiPAP checks Q 4 hours and PRN, BiPAP 15/10; BMR 14; 50%FiO2, Albuterol/Atrovent Q 4 and PRN, CPT via vest Q 4 hours, Suction PRN" and was signed by (named) Respiratory Therapist. The entry did not state the name of the physician giving the order or if it was a verbal or telephone order." An entry on the Physician order sheet for 11/15/10 at 0817 included "ABG's today to check respiratory status" and was signed "per protocol (named) Respiratory Therapist. The entry did not name of the physician giving the orders or if it was a verbal or telephone order. The findings were confirmed by the Director of Clinical Services on 11/18/10 at 1040.
C. Patient #3 was admitted to the facility on 10/27/10 with a diagnosis of Respiratory Failure Atrial Fibrillation, COPD (Chronic Obstructive Pulmonary Disease) and CHF (Congestive Heart Failure). An entry on the Physician's Order sheet 11/06/10 at 1812 listed "Respiratory Orders: D/C CPT, Continue all other Respiratory Orders and was signed by (named) Respiratory Therapist. Another entry dated 11/07/10 at 1345 lists "ABG;s to assess respiratory status" and was signed by (named) Respiratory Therapist. The entries on 11/06/10 and 11/07/10 did not state the name of the physician giving the orders or that the entry was a verbal or telephone order. The findings were confirmed by the Director of Clinical Services on 11/18/10 at 1100.
D. Patient #4 was admitted to the facility on 11/01/10 with a diagnosis of Infected Gastrostomy tube, severe malnutrition. Admission orders included "Respiratory evaluation and respiratory protocol. Duoneb updrafts Q 4 hours while awake." An entry on the Physician's order sheet on 11/02/10 (not timed) stated "Respiratory orders as follows: Assessment Q day, Duoneb Q 4 hours W/A (while awake), Suction PRN as needed". The entry was signed by (named) Respiratory Therapist. An entry dated 11/04/10 at 1549 stated "Respiratory Therapy: D/C RT assessment, D/C PRN med nebs, Respiratory available to reassess as needed." The entry was signed by (named) Respiratory Therapist. The entries did not state the name of the physician give the orders or that the entry was a verbal or telephone order. The findings were confirmed by the Director of Clinical Services on 11/18/10 at 1046.
E. Patient #5 was admitted to the facility 11/01/10 with a diagnosis of Pulmonary Edema, Respiratory Failure, and Severe Malnutrition. Admission orders included "Respiratory evaluation and Respiratory Protocol." An entry on the Physician's orders 11/04/10 at 1615 stated "Respiratory orders: BiPAP at HS and PRN, Settings 12.5; FiO2 45%, O2 at 2 lpm (liters per minute) NC (nasal Cannula) when not wearing BiPAP, RT assessment daily" and was signed by (named) Respiratory Therapist. The entry did not state the name of the physician giving the orders or that the entry was a verbal or telephone order. The findings were confirmed on 11/18/10 by the Director of Clinical Services.
F. Patient #8 was admitted to the facility on 10/25/10 with a diagnosis of Respiratory Failure and Severe malnutrition. Admission orders included "Respiratory evaluation and respiratory protocol." An entry on the Physician's Order sheet for 10/27/10 at 0828 stated "RT orders; RT assessment daily, albuterol QID and PRN, O2 to maintain SpO2 greater than 92%, Trach care Q HS (hour of sleep) and PRN, Suction PRN. An entry 10/27/10 at 1355 on the Physician's Order Sheet stated "Respiratory Orders: D/C Albuterol QID, Start Albuterol/Atrovent TID (three times per day) and PRN, RT assessment daily, Trach care Q HS and PRN." The entry was signed by (named) Respiratory Therapist. An entry dated 11/04/10 (no time) stated "Respiratory Orders: RT to assess Day, SIM check 8 450 PS 10 Peeps at i 50, Albuterol/Atrovent TID and PRN, Symbicort 4 puffs BID, Trach (tracheostomy) Care at HS and PRN, Suction PRN, RT to manage vent per SpO2 and ABG results" and was signed "Per Protocol (named) Respiratory Therapist. The entries did not stated the name of the physician giving the orders or that the entry was a verbal or telephone order. The findings were confirmed by interview with the Director of Clinical Services on 11/18/10.
G. Patient #9 was admitted to the facility 10/26/10 with a diagnosis of Pneumonia and Multiple Skin Ulcers. An entry in the clinical record dated 10/27/10 at 0840 listed "Respiratory Orders: D/C Mucomyst Q 6, D/C Albuterol QID, D/C Atrovent QID, Start Albuterol/Atrovent Q 6 and PRN, Start Mucomyst BID 2 cc (cubic centimeters) 20% solution, O2 to maintain SpO2 greater than 92% Wean as tol (tolerated) x 1 day, Daily RT assessment" signed (named) Respiratory Therapist. The entry did not state the name of the physician giving the order or that the entry was a verbal or telephone order.
H. Patient #14 was admitted to the facility on 11/10/10 at 2100 with a diagnosis of Bilateral lower lobe pneumonia and Urinary Tract Infection. Admission orders included "Respiratory evaluation and respiratory protocol" An entry on the Physician's Orders section of the clinical record on 11/11/10 at 1225 stated "Respiratory Orders; RT assessment daily, O2 Check BID and PRN, O2 to keep SpO2 greater than 92% wean as tolerated" and was signed by (named) Respiratory Therapist. The entry did not state the name of the physician giving the order or that the entry was a verbal or telephone order. The findings were confirmed by interview on 11/18/10 at 1040 by the Director of Clinical Services.
I. The Respiratory Director was interviewed 11/16/10 at 1345 and stated "we don't have protocols, the Therapist has to call the doctor for all respiratory orders." In an interview 11/16/10 at 1355, Respiratory Therapist #1 stated "Orders are based on protocols. We have a Protocol Book and we can write orders if it is on protocol" and confirmed the physician was not contacted for medication or treatments changes based on "Protocols".
On 11/16/10 at 1410, the Director of Respiratory was informed Respiratory Therapist #1 stated orders were written from a Protocol Book and the physician was not contacted for a verbal or written order for changes in medications or treatment for "Protocols". The Respiratory Director confirmed there was not a process in place and there was not current policy for the use of Protocols. On 11/18/10 at 1145, the Director of Clinical Services (DCS) was interviewed regarding orders for respiratory care in the clinical record, she stated "I would expect to see Physician orders for Respiratory care documented according to policy".
J. Facility policy CS3F -1 "Respiratory Services" stated "Patients admitted to (hospital named) will have access to respiratory therapy services based on orders written by their physician. Respiratory services will be provided based on Physician's Orders and will be carried out by qualified staff from the respiratory department."
K. Facility Policy #CS9-16 "Physician Orders" stipulates"There shall be Physician's orders for medical and functional management written for each patient specific to their own needs. All Physician's Orders will be dated and timed when written. Additionally, orders will have a time frame specific to how long that order is to be followed. Verbal orders may be accepted by an RN (Registered Nurse), RT (Respiratory Therapist), PT (Physical Therapist), OT (Occupational Therapist), Pharmacist, and ST (Speech Therapist). Such orders will be written by the person accepting the order noting date and time. Verbal orders will be co-signed by the physician within 72 hours."
L. Facility Policy #3066 "Respiratory Care: Arterial Blood Gas Sampling-Recommended Parameter" stated "It is the policy of (hospital named) Respiratory Care Services to provide sampling for arterial blood gas analysis, as ordered by a patient's physician."
M. Facility Policy #3026 "Respiratory Care Services: Verification of Respiratory Medications (inhaled) for Respiratory Care Services" stated "Except as noted for self-administered PRN doses and the self-administration program described below, all medications will be administered as ordered by the physician, by an authorized health care professional and verified for dosage/contraindications by the pharmacist. "A Respiratory Therapist approved to administer respiratory medications under medical supervision may administer respiratory medications to the patient as ordered by the physician."
N. Facility Policy #CS9-12 "Verification of orders/Critical Test Results" stated "Telephone/Verbal Orders: Personnel will attempt to have physicians write orders at the time of patient's rounds and to clarify these orders with them to prevent misinterpretations. Personnel will obtain telephone or verbal orders from physicians according to established standards: Personnel authorized to receive telephone and verbal orders are: Registered Nurses, Licensed Practical Nurses, Registered Pharmacists, Other registered or certified professional with their sphere of practice and competence. Documentation Required for written orders, verbal orders shall include: The date and time of entry, the prescribing practitioner's name, the signature and title of the person who accepted the order, the letters RB indicating that the order was read back to the physician verifying the order was recorded correctly in the patient's chart."

Based on review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007 and interview with the Director of Clinical Services, it was determined the facility did not develop quality indicators for all patient care departments to collect and analyze data to identify potential problems and failed to monitor the follow-up actions of Radiology, Health Information Management and Dietary. The failed practice resulted in the facility being unable to monitor the delivery of patient care for Nursing Service, Respiratory Therapy, Radiology, Dietary and Health Information Management. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:

A. Review of the Performance Improvement Regulations 2007, page 7, revealed the following: "Each service and performance improvement team shall review the findings of its performance improvement activities. A report of these activities must include a summary of data reviewed, adverse trends or opportunities to improve and corrective actions to be taken, as well as the results of corrective actions already initiated and a follow-up plan. All reports are provided to the QAPI (Quality Assurance/Performance Improvement) Committee at least quarterly."
B. Review of the Quality Assurance/Performance Improvement Meeting Minutes for January through October 2010, revealed indicators for Dietary, Radiology, and Health Information Management remained unchanged. There was no evidence these departments were implementing plans of correction for items when goals were not met or adding new indicators when existing goals were met. Examples follow:
1) Radiology monitored film reject analysis with a goal of 10%. The goal was not met in 2010. The follow-up action each quarter was educate staff on patient positioning.
2) Health Information Management monitored the timeliness of History and Physical Examinations and Discharge Summaries being dictated by the physician. The follow-up action each quarter was communicate more effectively with physicians.
3) Dietary monitored the tray line time audits, correct diet orders, correct diet ticket, correct food temperatures, and refrigerator log. The goal of 80% was met every quarter.
C. Review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010 revealed there was no evidence of Quality Assurance/Performance Improvement activities being reported for Nursing Services since June 2010.
D. Review of the Quality Assurance/Performance Improvement Meeting Minutes for January through October 2010 revealed there was no evidence of Quality Assurance/Performance Improvement activities being reported for Respiratory Therapy since April 2010.
E. Findings were confirmed in interview with the Director of Clinical Services at 1515 on 11/16/10.

Based on review of the Quality Assurance/Performance Improvement Meeting minutes for January through October 2010, Performance Improvement Regulations 2007, Policy and Procedure CS1-10 Restraints, 3 of 3 active clinical records of patients in restraints and interview with the Director of Clinical Services, it was determined the facility failed to monitor the use of restraints per facility policy. The failed practice had the potential to allow patients to be placed in restraints without a physician's order, without being assessed and without least restrictive measures being attempted. The failed practice had the potential to affect the current patient census of 16 and the average daily census of 18 patients. Findings follow:

A. Review of the Performance Improvement Regulations 2007, page 6, revealed the facility would measure the use of restraints.
B. Review of the Quality Assurance/Performance Improvement Meeting Minutes for January through October 2010 revealed there was no evidence of monitoring the use of restraints since June 2010.
C. Review of active Clinical Record #08 revealed nursing notes dated 10/27/10 at 0800 stated the patient' s left wrist was restrained. A nursing note dated 10/27/10 at 2000 stated bilateral wrist restraints were in place. There was no evidence of a signed physician order for wrist restraints on 10/27/10. A nursing noted dated 10/29/10 at 2400 stated side rails were up times 4. There was no evidence of a signed physician order for side rails up times 4 on 10/29/10. A nursing note dated 10/31/10 at 2200 stated the "restraints loosened, not off, not taut." There was no evidence of a signed physician order for restraints on 10/31/10. A nursing note dated 11/03/10 at 2000 stated the patient was in bilateral wrist restraints. There was no evidence of a signed physician order for bilateral wrist restraints on 11/03/10. A nursing note dated 11/04/10 at 2015 stated bilateral wrist restraints were in place to prevent the patient from pulling lines and tubes. There was no evidence of a signed physician order for bilateral wrist restraints on 11/04/10.
D. Review of active clinical record #12 revealed a physician order for wrist restraints dated 11/17/10 at 0700 was not signed by the physician at 1400 on 11/18/10.
E. Review of active clinical record #15 revealed nursing notes dated 11/11/10 at 2400 stated side rails were up times 4 and the patient was in bilateral wrist restraints. Nursing notes dated 11/12/10 at 0500 stated side rails were up times 4. Nursing notes dated 11/13/10 at 0400 stated the patient was in bilateral soft wrist restraints. There were no signed physician orders for side rails up times 4 on 11/11/10 and 11/12/10. There was not a signed physician order for bilateral soft wrist restraints on 11/13/10.
E. Review of clinical record #29 revealed nursing notes dated 08/20/10 at 0200 stated the patient was attempting to pull out a catheter and get out of bed. A physician's order was timed at 0200 and signed by the physician but did not have a date. A nursing note dated 08/21/10 at 0400 stated the patient was in bilateral wrist restraints. There was not a physicians order for the bilateral wrist restraints used on 08/21/10.
F. Findings were confirmed in interview with the Director of Clinical Services at 1515 on 11/16/10.

Based review of the Radiology Policies, review of cardiopulmonary resuscitation (CPR) certifications and interview, it was determined the facility failed to ensure five of five (#1-#5) Radiology Technologists met requirements for current CPR certification. The failed practice had the potential to affect the safety of all patients receiving x-rays in that the radiology personnel were not currently trained to perform CPR in emergency situations. Evidence follows:

A. Review of the Radiologic Technologist Job Description Policy revealed Radiologic Technologists were required to have current CPR certification.
B. Review of CPR documentation for Radiologic Technologists revealed five of five lacked current CPR.
C. The above was confirmed by the Radiology Supervisor at 1020 on 11/16/10.

Based on review of Dietary Policies and Procedures provided by the Dietary Director and interviews, it was determined the facility lacked a policy and a procedure for ensuring menus were modified for patients with potential food/drug interactions. The failed practice had the potential to affect all patients taking medications that could interact with foods provided. Evidence follows:

A. Review of the Dietary Policies and Procedures provided by the Dietary Director revealed a lack of a procedure to adjust patient menus according to food/drug interactions.
B. Interview with the Director of Pharmacy at 1515 on 11/15/10 revealed the computer system "usually flagged a drug with a serious concern." She stated she told nursing first and then dietary. She could not name any specific drugs that were monitored.
C. The Dietary Director stated the Registered Dietitian would modify the diets of patients on Coumadin, but only when she discovered they were receiving it. She confirmed the lack of a procedure to modify menus according to patients with food/drug interactions during interview at 1520 on 11/15/10.