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Based on medical record review and staff interview, the facility failed to ensure information related to advanced directives was available for 2 of 18 sample patients (#4, #6) reviewed for those directives. In addition, 2 other sample patients (#14, #16) indicated they did not have advanced directives, but the records lacked evidence they were offered information on that topic. The findings were:

1. According to the medical record, patient #6 had a living will in place. However, further review failed to show evidence of the patient's wishes, and there was no evidence the patient had been asked to provide that information. On 9/7/11 the RN manager checked the book for advanced directives, kept in the emergency department, but was unable to find a copy. On 9/8/11 at 5:20 PM RN #4 stated the patient's living will had not been obtained.

2. Medical record review with the nursing manager showed patient #4 was admitted on 9/6/11 for observation. Further review showed the patient had a living will, but his/her wishes were not indicated, and there was no documentation the patient or representative had been requested to provide the facility with a copy. Prior to the patient's discharge on 9/7/11, the RN manager reviewed the book for advanced directives, but was unable to find a copy of the patient's living will.

3. The medical record for patient #14 was reviewed on 9/8/11 at 8:35 AM with RN #9. According to the documentation, the patient did not have advanced directives. When that screen in the electronic medical record was opened, there was no documentation the patient had been offered information concerning advanced directives. During the review, RN #9 confirmed the lack of evidence indicating the patient was provided with information regarding advanced directives.

4. Review of the medical record with RN #9 revealed patient #16 did not have advanced directives in place. Further review showed no evidence the patient was offered information concerning advanced directives. The RN confirmed this lack of evidence on 9/8/11 at 10:15 AM.

21849


Based on observation, staff interview, and review of facility policies and procedures, the hospital failed to ensure 2 of 2 vents were cleaned in the kitchen food preparation area. The facility further failed to ensure 1 of 26 non-dietary refrigerators were cleaned regularly. In addition, the facility failed to ensure 1 of 1 emergency eye wash stations in the sterile processing area functioned correctly. The findings were:

1. Observation in the kitchen on 9/7/11 at 3:10 PM showed an accumulation of dust and debris in the exhaust hood over the range and stove tops, to include 5 of 5 fire suppression nozzles and associated hoses. In some areas within the hood, the accumulation was more than 1/4 inch thick. A similar dust buildup was observed in the air vent and diffuser over the 3-compartment sanitizing sink.
The registered dietitian and dietary manager accompanied the surveyor on an extended tour of the kitchen and food preparation areas; both acknowledge in interview on 9/8/11 at 3:30 PM that the accumulation of dust in the hood and vent were excessive. At this time, the registered dietitian stated the maintenance department was supposed to clean the hoods and vents at least monthly.
Subsequent tour with the maintenance director on 9/9/11 at 9 AM showed the same accumulation of dust and debris as noted. He stated while on tour that he had purchased a small push broom for dietary staff to use when cleaning the hood. A search for the broom revealed it was in a maintenance workshop across the hallway from the kitchen; the broom head was dirty and showed evidence of use in the workshop.

2. Observation of a refrigerator in the surgical suite on 9/7/11 at 10 AM showed it contained various individual beverages, identified by RN #6 as being for patients. The observation also showed a build-up of ice inside the refrigerator and freezer compartment. After checking with environmental services and nursing, at 10:40 AM the RN manager stated nursing was responsible for cleaning the refrigerator, but no one knew the date it was last cleaned. According to information compiled by environmental services, there were 26 non-dietary refrigerators in the facility.
Review of the facility's undated policy and procedure entitled, "Care and Cleaning of Refrigerators" revealed environmental services was responsible for "recording temperatures and cleaning public use refrigerators. All other departments are responsible for temperature monitoring and the cleaning and defrosting...of their department refrigerators."

3. While touring the sterile processing area on 9/7/11 at 8:25 PM, an emergency eye wash apparatus was observed affixed to a sink faucet. When asked to demonstrate the eye wash, employee #8 stated the water line did not produce enough water pressure to properly operate the emergency device. He then fully opened the faucet supplying the eye wash and the water was observed to dribble from the eye wash outlets; it did not achieve a flow sufficient to rapidly irrigate the eyes.
Techniques observed in sterile processing and endoscopic reprocessing included two high-level chemical disinfectants, Rapicide and Cidex OPA. The material safety data sheets (MSDS) for both products cautioned against exposure to the eyes and stated in the case of accidental exposure the eyes should be flushed with copious amounts of water for at least 15 minutes. The eye wash demonstration observed on 9/7/11 in the sterile processing room did not produce a volume and flow of water that met the manufacturers' MSDS description ("copious") for emergency response to exposure.

Based on observation, staff interview, and review of medical records and policies and procedures, the facility failed to enforce their policy and procedure for reporting medication occurrences for 3 of 3 sample patients (#3, #5, #14) identified with medication occurrences. The findings were:

According to the facility's policy and procedure, "Pharmacy: Medication Occurrences", last reviewed 5/13/10, an occurrence is a "lapse in the medication process during the selection/procurement/storage, prescribing, transcribing, dispensing, or administration of a medication..." Further review showed reportable occurrences included "...Documentation inaccurate or lacking pertinent information...Performance deficit...Procedure/protocol not followed..." Deficient practice related to failure to implement this policy and procedure was identified as follows:
a. On 9/6/11 RN #11 was observed while administering medications for patient #3 at 5:43 PM. After correctly administering two other medications, the RN identified a 500 mg tablet of Calcium Carbonate and handed it to the patient. The patient laid it on the meal tray, and the RN left the room without ensuring the patient actually consumed the tablet. During an interview on 9/7/11 at 1:12 PM, both the senior manager and the RN manager stated medications were not to be left at a patient's bedside as there was no way to guarantee they were taken.
b. Medical record review on 9/8/11 at 8:35 AM with RN #9 showed documentation that six milliliters of Morphine was used from a PCA pump for patient #14. However, review of the MAR showed no evidence the pump and Morphine were actually utilized by the patient. During the record review, the RN manager verified lack of accurate documentation.
c. On 9/9/11 at 8:26 AM RN #7 scanned medications, including Colace 100 mg, into the electronic MAR for patient #5. At 8:30 AM that morning the RN was observed while administering the medications to the patient. Unbeknownst to the RN, the package of Colace was underneath a piece of paper on the computer stand. The RN did not recognize a medication was omitted until pointed out by the surveyor.

On 9/9/11 at 8:50 AM the manager of quality and risk stated she was aware of the first two errors but had not received an occurrence report. The manager was unaware of the third occurrence, but she stated staff were to complete and submit the reports on line "right away."

Based on observation, staff interview, and review of facility policies and procedures and manufacturer's product label information, the hospital failed to monitor the expiration dates for 3 of 3 control materials used to verify high-level disinfection and sterilization processes. The facility further failed to enforce acceptable infection control practices to require personnel to wear appropriate PPE in restricted areas. The findings were:

1. Tours of the endoscopy reprocessing area and sterile processing rooms on 9/8/11 at 7:25 AM showed high-level disinfection of semicritical medical items, such as flexible endoscopes and camera heads, was performed. Sterile processing technician #8 stated while on tour that he performed quality control checks on two different types of high-level disinfectants using chemical test strips. Inspection of the label information on the bottles of test strips revealed the manufacturer limited the usable life of the product to 90 days after the bottles were initially opened.
Further observation on tour showed a box of biological indicators (BIs) used to verify the operation of steam sterilizers. The product label showed a lot number of 2008-11AD, but the box top had been removed for easier access to the biological indicator vials. The entry for "expiration date" was covered by a sticker on the end flap of the box. Inspection of several other boxes of BIs in a storage room revealed the lot number was the expiration date with the addition of a two-letter suffix. Telephone interview with a manufacturer's technical representative on 9/9/11 at 9:10 AM confirmed the BI lot number 2008-11AD expired in November 2008.
Interview with the processing technician on 9/8/11 at 9:10 AM revealed he was not aware quality control test strips had a 90-day open bottle stability, nor did he routinely record the date a bottle was opened.

2. Observations were made in the endoscopy procedure room on 9/8/11 beginning at 7:25 AM; prior to touring the procedure room, surveyors were instructed by ICP #2 to don PPE. The ICP provided disposable overgarments, shoe covers, and hair covers for the surveyors. She stated PPE was required to enter the procedure room and surgical areas.
The endoscopy procedure room was entered on 9/8/11 at 7:32 AM and 3 hospital staff were observed finishing a colonoscopy procedure. Two of the staff were wearing surgical scrubs and gloves, but surgeon #1 was observed in street clothes and shoes while he made chart entries regarding the colonoscopy. He had no gloves, mask, or shoe covers on at the time he was observed in the procedure room.
Review of the facility's policy "Perioperative Services: Surgical Attire in Restricted and Semi-Restricted Areas" dated 12/9/2010 showed the facility required all staff to wear appropriate PPE in surgical and procedural environments. The policy required, at a minimum, that staff wear clean hospital scrubs and, as appropriate, additional PPE such as gloves, shoe covers, hair covers, and masks. ICP #1 provided the policy for review and acknowledge the document as current.
The Centers for Disease Control and Prevention (CDC) recommend the use of PPE for endoscopists and assistants. The Occupational and Safety Health Administration (OHSA) requires the use of PPE in an environment where blood borne pathogens or OPIM [other potentially infectious materials] from splashes, splatter, or droplets could potentially occur. OHSA cites endoscopy as a likely area of OPIM contamination for healthcare workers.
Recommendations of the American Society for Gastrointestinal Endoscopy presented in the Gastrointestinal Endoscopy Journal, volume 72, number 2, 2010, pp 227-235, endorses the use of PPE in endoscopy procedures to prevent exposure to endoscopist and their assistants.

Based on staff interview and review of policies and procedures, the facility failed to ensure all policies were reviewed annually. The findings were:

During an interview on 9/7/11 at 3:06 PM, the pharmacy manager stated most pharmacy policies and procedures were reviewed every two years. Review of several policies and procedures from different departments verified they had not been reviewed annually. The following is a partial list of policies and procedures from various departments and their review dates:
a. Care and Cleaning of Refrigerators; undated;
b. Care of Labor Patient with Epidural Anesthetic; undated;
c. Blood Components Transfusion, Number: 9551, Version: 9551.1; last reviewed 4/1/2007;
d. Incident Reporting, Serious and Sentinel Event Reporting, Number: 9062, Version 9062.2; last reviewed 3/31/08;
e. Pain Management, Number: 9171, Version: 9171.2; last reviewed 5/8/08;
f. Use of Hot Fluid Warmer (HL-90)/DW 1000A Warmer; reviewed 3/17/09;
g. Compliance: Outpatient Status; Observation and Extended Recovery; last reviewed 7/21/09;
h. Pharmacy: Medication Occurrences, Number: 9395, Version: 9395.4; last reviewed 5/13/10; and
i. Barcode Medication Administration, Number: 12657, Version: 12657.1; last reviewed 8/25/10.

Based on staff interview and medical record review, the facility failed to ensure that all contracted patient care services were in compliance with the applicable conditions of participation. The findings were:

Interview with the PI coordinator on 9/8/11 at 1:50 PM revealed the hospital had been without a PI coordinator from January 2011 until June 2011. She stated patient care related contracted services were not involved in PI at this time. Review of the PI reporting schedule for 2011 showed the contracted services for organ and tissue procurement, cardiovascular services, and sleep studies were not included.

18512

Based on staff and patient interview, medical record review, and review of facility policies and procedures, the facility failed to ensure all necessary assessments, monitoring, and nursing measures were implemented for effective and consistent pain management for 5 of 23 sample residents (#3, #6, #14, #19, #20,) reviewed for pain. In addition, patient #6 was not appropriately assessed and monitored for recovery from epidural anesthesia. The findings were:

1. Review of the 9/2/11 re-admission history and physical (H & P) for patient #3 showed s/he was admitted with a diagnosis of hip fracture post surgical repair and evacuation of hematoma at the surgical site. Review of 9/2/11 physician's orders showed PRN (as needed) orders for Tramadol 50 mg or Vicodin 5/500 mg for pain. Review of the 9/2/11 MAR entry showed the patient's acceptable level of pain was 2 on a 0 (no pain) to 10 (worst pain) scale, 2/10). The following concerns were identified:
a. Review of the 9/2/11 pain flow sheet showed that at 6:26 PM the patient had pain rated at an intensity of 8/10. Review of the 9/2/11 MAR showed s/he received a Vicodin 5/500 mg at that time. Review of the pain reassessment at 7:26 PM showed it remained at 8/10. Continued review showed the next pain medication administered was a Tramadol 50 mg tablet at 11:42 PM that evening (9/2/11), over five hours later. Finally, review revealed no evidence the patient's pain was again assessed until 10:41 AM the following morning (9/3/11), at which time his/her pain intensity was 5/10 and required the administration of Vicodin 5/500 mg at that time.
b. Review of the September 1 through 8, 2011 pain flow sheet showed on 9/6/11 at 5:14 AM the patient had pain rated 4/10. At that time the patient was administered one Tramadol 50 mg tablet. Reassessment at 6:14 AM showed the patient had not improved and remained at 4/10. Review of the record showed no further medications or pain interventions were implemented until 1:12 PM (7 hours later) at which point the patient received another Tramadol 50 mg tablet for the pain.
c. During an interview with the patient on 9/7/11 at 3:10 PM, s/he said the pain pills helped take the "edge" of the pain but did not relieve it.
d. Interview with the nurse manager on 9/9/11 at 8:10 AM verified this patient did have a lot of pain.

2. Review of the 4/15/11 H & P for patient #20 showed s/he had a diagnosis of end stage rheumatoid arthritis with a history of a septic joint. The problems identified on the current care plan showed pain was a chronic and continual problem. Review of the physician's orders showed the patient had Percocet 5/325 mg one to two tables ordered for pain. The following concerns were identified:
a. Review of the September 1 through 8, 2011 MAR and pain flow sheet showed the patient received two PRN Percocet 5/325 mg tablets for pain eight times. There was no evidence a reassessment was performed to determine the effectiveness of the Percocet in resolving the patient's pain for five of those eight times (62.5 %). On two of the eight occasions, the reassessment was performed but not for three to four hours after administration of the pain medication.
b. Continued review of the aforementioned MAR showed, that on three of the occasions a PRN medication was given for pain, there was no description, location, or intensity of the pain documented on the pain flow sheet or the MAR.

3. Medical record review revealed patient #6 delivered an infant at 12:16 AM on 9/6/11. Review of the orders, assessments, and MARs after delivery showed the patient received ibuprofen at 2:30 and 9:03 AM and 3:20 PM on 9/6/11. However, a descriptive assessment of the patient's pain prior to administration of the medication was lacking, and timely reassessment after administration only occurred after the 9:03 AM dose. The other reassessment times were over 2.5 to 3 hours later, at 5:08 AM and 6:37 PM, respectively. At 5 PM on 9/8/11, RN #4 confirmed the lack of appropriate pain assessments, documentation, and monitoring.
Record review also revealed the patient received epidural anesthesia on 9/5/11. Review of the documentation showed no evidence the patient was routinely monitored for recovery from the anesthetic. Dermatone levels were documented on 9/6/11 at 12:27 AM and 12:53 AM; however, there was no further documentation related to recovery from the anesthetic until 5:33 AM, over 4.5 hours later. After reviewing the record on 9/9/11 at 10:50 AM, RN #3 verified the lack of documented monitoring. According to the facility's undated policy and procedure, "Care of Labor Patient with Epidural Anesthetic," evaluation of the patient's status was to occur every hour until full sensation and use of the lower extremities was recovered.

4. According to the surgical record, a laparoscopic surgical procedure was converted to an open one for patient #14 on 7/8/11. Review of pain assessments and documentation after surgery showed the patient received Toradol (pain medication) on 7/8/11 at 4 PM and 10:30 PM and on 7/9/11 at 4 PM and 11:05 AM. In addition, review showed documentation that the patient's pain level was assessed prior to administration of the medication only at 4 AM on 7/9/11. Furthermore, there was no evidence the patient's pain was ever reassessed. Finally, even though the patient's acceptable level of pain was listed as 2/10 on 7/8/11, there was no evidence the patient's pain was treated at 7:33 PM when rated at 4/10. The lack of documentation was confirmed during the record review by RNs #9 and #10.

5. Review of the medical record showed patient #19 delivered an infant on 9/3/11 and underwent a surgical procedure on 9/4/11. Further review showed the patient received a narcotic on 9/3 at 11:10 PM; at 3:10 PM and 9:03 PM on 9/4; and at 12:40 AM, 6:40 AM, and 10:35 AM on 9/5/11. Additionally, the patient received ibuprofen at 8:32 AM and 8:47 PM on 9/3; at 3:47 PM on 9/4; and at 3:42 AM on 9/5/11. Comparison of those times with documentation of the patient's pain scale ratings showed a lack of assessment prior to medication administration and/or follow-up reassessment after administration to determine the effectiveness of treatment. The senior manager confirmed the findings on 9/8/11 at 4:55 PM.

6. Review of page 3 of the hospital's pain policy, "Pain Management, Number: 9171, Version: 9171.2", last reviewed 5/8/08, revealed the following instructions: "... re-assess the patient after medication administration to assess the impact of the medication on pain severity and document." Interview with the nurse manager on 9/9/11 at 8:10 AM revealed pain should be re-assessed within two hours after medication administration. Further review of the pain policy, page 2, showed the "...description of pain, location, intensity/severity (pain rating scale), verbal rating on a 0-10 scale...aggravating/relieving factors..." may be included in the assessment and management of pain.

Based on observation, medical record review, and staff interview, the facility failed to ensure medications were administered correctly. This failure resulted in an error rate of 13.3 percent (%) and affected 2 of 3 patients observed during medication passes (sample patients #3 and #5). The findings were:

1. On 9/6/11 RN #11 was observed while administering medications for patient #3 at 5:43 PM. The RN identified a 500 mg tablet of Calcium Carbonate and handed it to the patient who laid it on the meal tray. The RN then left the room without ensuring the patient actually consumed the tablet. Reconciliation of the medication pass with the physician's orders verified the patient should have received the medication. During an interview on 9/7/11 at 1:12 PM, both the senior manager and the RN manager confirmed this constituted a medication error.

2. On 9/9/11 at 8:26 AM RN #7 scanned Colace 100 mg into the electronic MAR for patient #5. At 8:30 AM that morning the RN was observed while administering medications to the patient. Unbeknownst to the RN, the package of Colace was underneath a piece of paper on the computer stand. This constituted an error of ommision as the RN was unaware the medication had not been administered until pointed out by the surveyor.

Based on observation, medical record review, staff interview, and review of policies and procedures, the facility failed to ensure medical records were complete and accurate (C-0302). The facility further failed to safeguard the confidentiality of health information by restricting access to only those employees involved in patient care, quality assessment and utilization review, and health information management (C-0308). The cumulative effect of these deficiencies resulted in a determination the facility failed to meet the requirements for the condition of participation for clinical records.

Based on medical record review, staff interview, and review of policies and procedures, the facility failed to ensure records for 4 of 23 sample patients (#6, #14, #16, #17) were complete and accurate. The findings were:

1. Review of the medical record showed patient #6 received epidural anesthesia on 9/5/11. Further review showed no documentation the epidural catheter was removed or that the patient was appropriately monitored for pain and recovery from the anesthesia. At 5 PM on 9/8/11, RN #4 confirmed the lack of appropriate pain assessments, documentation, and monitoring. After reviewing the record on 9/9/11 at 10:50 AM, RN #3 verified the lack of monitoring for recovery from the epidural. On 9/9/11 at 1:25 PM, the senior manager confirmed lack of documentation regarding removal of the epidural catheter.

2. According to the admission record, patient #14 did not have advanced directives. After opening the electronic medical record, there was no evidence the patient was offered information concerning advanced directives. During the review on 9/8/11 at 8:35 AM, RN #9 confirmed the facility failed to provide the patient with information regarding advanced directives.
According to the surgical record, the patient underwent both an attempted laparoscopic and an open surgical procedure on 7/8/11. Review of pain assessments and documentation after surgery showed the patient received Toradol (pain medication) four times between 7/8/11 and 7/9/11. However, evidence was lacking that the patient's pain level was assessed prior to administration of three of the doses, and there was no evidence the the patient was reassessed to determine the efficacy of the medication. Finally, there was no evidence the patient's pain was treated at 7:33 PM on 7/8/11 when rated at '4', a rating above the patient's acceptable level of pain. The lack of documentation was confirmed during the record review on 9/8/11 at 8:35 AM by RNs #9 and #10.
Medical record review showed documentation that six milliliters of Morphine was used from a PCA pump supposedly assigned to the patient on 7/8/11. However, review of the MAR showed no evidence the pump or the Morphine was actually utilized by the patient. During the record review on 9/8/11 at 8:35 AM, the RN manager verified lack of accurate documentation.

3. Review of the medical record with RN #9 revealed patient #16 did not have advanced directives in place. Further review showed no evidence the patient was offered information concerning advanced directives. The RN confirmed this lack of evidence on 9/8/11 at 10:15 AM.

4. Findings identified by the laboratory were missing for 1 of 3 inpatient medical records (patient #17) reviewed on 9/8/11 for blood transfusions. The patient's record included two transfusion worksheets dated 2/19/11; these documents were labeled by laboratory personnel with a red precautionary label marked with bold capital letters "USE BLOOD WARMER." There was no further documentation in the medical record to explain why a blood warmer was necessary; nor was there evidence to show a blood warmer was used during the 2 pRBC transfusions performed on 2/19/11. A detailed review of the medical record with the RN manager further failed to uncover a rationale for a blood warmer or any evidence a warmer was used.
The laboratory manager stated in interview on 9/8/11 at 4:20 PM that patient #17 was found to have a condition termed "cold agglutinins" when the patient's pretransfusion compatibility tests were performed on 2/18/11. This finding prompted the precautionary labeling of the transfusion worksheets, but the laboratory report was not entered into the patient's medical record. The manager acknowledged the findings of cold agglutinins was not entered in the patient's medical record, an oversight by laboratory personnel. He further stated warming the pRBCs during transfusion reduced the potential risk to a patient with cold agglutinins. The manager added that he did not find evidence the findings were communicated between the laboratory and the provider or nursing staff prior to the transfusion events.




21849

Based on observation, staff interview, and review of facility policies and procedures, the hospital failed to safeguard the confidentiality of medical information in 2 of 2 record storage areas. The findings were:

While conducting a Life Safety Code (LSC) survey on 9/06/11 at 4:33 PM, the LSC surveyor observed the facility maintenance supervisor enter a medical records storage area. When asked by the surveyor, the maintenance supervisor acknowledged he had unrestricted access to the primary medical records room as well as an archive room for older medical and business records.
Interview with the health information manager on 9/7/11 at 10:20 AM confirmed the maintenance director had a key to both records storage areas. The health information manager acknowledged the maintenance department had no need to access confidential medical information.
The maintenance supervisor confirmed in interview on 9/7/11 at 4:10 PM that he had a master key that opened medical records storage and archive rooms. During the exit conference on 9/9/11 at 3 PM, the administrator, health information manager, and the maintenance supervisor confirmed the need to rekey the records rooms, but acknowledged corrective actions to restrict access to these rooms had not been implemented prior to the survey team exiting the facility on 9/9/11 at 3:35 PM.
Facility policy, "Records Retention and Destruction" dated 8/11/2011, was reviewed on 9/8/11; the policy required hospital employees to store and maintain records in a manner that protected the confidentiality, privacy, and security of medical information.

18512

Based on staff interview and medical record review, the facility failed to ensure staff discharged 3 of 4 sample surgical patients (#11, #14, #19) in the company of a responsible adult. The findings were:

1. Review of the operative report for patient #11 showed s/he had a total abdominal hysterectomy with a bilateral salpingo-oophorectomy and lymph node dissection on 8/25/11. Review of the discharge records showed no evidence the patient was discharged to a responsible adult. Interview with the nurse manager on 9/9/11 at 8:10 AM verified there was no evidence the patient was discharged to a responsible adult.

2. Medical record reviews showed patient #14 underwent surgical procedures on 7/8/11. Detailed review of the record showed no documentation the patient was discharged in the company of a responsible adult. During an interview on 9/8/11 at 3:20 PM, RN #6 stated surgical patients were to be discharged in the company of a responsible person. However, on 9/9/11 at 12:55 PM RN #3 confirmed there was no evidence patient #14 was discharged with a responsible adult.

3. According to the medical record, patient #19 had surgery performed on 9/4/11 and was discharged the same day. On 9/8/11 at 3:20 PM RN #6 stated surgical patients were to be discharged in the company of a responsible person, but there was no documentation that occurred with this patient. At 4:30 PM on 9/8/11, RN #4 verified the lack of evidence.

Based on staff interview and review of PI documents, the hospital failed to ensure health care policies and procedures were review and revised as part of the annual PI program evaluation. The findings were:

1. Review of the following policies and procedures showed they were not reviewed and/or revised within the past year:
a. Care and Cleaning of Refrigerators; undated;
b. Care of Labor Patient with Epidural Anesthetic; undated;
c. Blood Components Transfusion, Number: 9551, Version: 9551.1; last reviewed 4/1/2007;
d. Incident Reporting, Serious and Sentinel Event Reporting, Number: 9062, Version 9062.2; last reviewed 3/31/08;
e. Pain Management, Number: 9171, Version: 9171.2; last reviewed 5/8/08;
f. Use of Hot Fluid Warmer (HL-90)/DW 1000A Warmer; reviewed 3/17/09;
g. Compliance: Outpatient Status; Observation and Extended Recovery; last reviewed 7/21/09;
h. Pharmacy: Medication Occurrences, Number: 9395, Version: 9395.4; last reviewed 5/13/10; and
i. Barcode Medication Administration, Number: 12657, Version: 12657.1; last reviewed 8/25/10.

2. Interview with the PI coordinator on 9/8/11 at 1:50 PM revealed the hospital was without a PI coordinator from January 2011 until June 2011. She stated there were no organized formal PI meetings until July 2011 and that some policies and procedures had not been reviewed annually as required.

Based on staff interview and review of PI information, the facility failed to ensure there was an effective PI program. The findings were:

Review of the hospital's compliance review data collection forms showed no evidence that collected data was analyzed, problems were identified, or corrective actions were implemented. Interview with the PI coordinator on 9/8/11 at 1:50 PM revealed the hospital had been without a PI coordinator from January 2011 until June 2011. She said departments continued to collect data but there were no formal meetings to analyze data and follow through with the PI process.

Based on staff interview and review of PI information, the facility failed to ensure all patient care services were evaluated. The findings were:

1. Interview with the respiratory therapy manager on 9/8/11 at 4:13 PM revealed this department had just begun to collect performance improvement data on asthma education in July 2011. He stated he had done an informal review of pneumonia but utilized no specific criteria and collected no data for analysis. The manager said no other PI had been completed over the past year.

2. Interview with the PI coordinator on 9/8/11 at 1:50 PM revealed the hospital was without a PI coordinator from January 2011 until June 2011. She said patient care related contracted services were not involved in the PI program at this time. Review of the 2011 PI reporting schedule showed the contracted services for organ and tissue procurement, cardiovascular services, and sleep studies were not included.

Based on staff interview and review of PI documents, the hospital failed to ensure problems that were identified were followed through and corrective actions were taken. The findings were:

1. Review of the laboratory's PI processes on 9/7/11 at 1:30 PM included a detailed review of blood usage records. These documents showed a pRBC unit that was transfused on 6/17/11 was identified by laboratory personnel as not meeting monitoring criteria for transfusions, specifically the patient's hemoglobin and hematocrit exceeded the established baseline values. The laboratory PI finding was reviewed by the laboratory director on 8/3/11 and he referred the transfusion to the patient's physician for clarification and comment. The laboratory had no further documentation to show the outcome of the PI review. Interview with the laboratory manager on 9/7/11 at 2:40 PM revealed his assessment was that PI data for blood usage was collected and submitted to the hospital, but did not generate effective feedback to evaluate the quality of transfusion services.

2. Interview with the medical staff coordinator on 9/8/11 at 2:20 PM revealed transfusion and blood usage reports were reviewed by the medical staff. She stated the associated meeting minutes did not distinguish transfusion events in a traceable manner, nor was there any information provided back to the laboratory for quality assessment review or program evaluation.

Based on review of information from the OPO, staff interview, and review of facility contracts, the facility failed to ensure all patient deaths occurring in 2010 were reported to the OPO for determination of each patient's medical suitability as a potential organ donor. The findings were:

Review of the 6/16/11 letter from the facility's OPO, revealed that 5 of 37 patient deaths (86%) occurring during 2010 were not referred to the donor information line for determination of each patient's medical suitability for organ donation. Further review of the letter showed that a 100% referral rate was required. Interview with the case manager/clinical educator on 9/7/11 at 4:30 PM verified that all of the deaths occurred in the facility and that the facility's OPO should have been notified. Review of the facility's 2011 contract with the OPO revealed the facility would refer all hospital deaths to the OPO via the donor information line."

Based on review of information from the OPO, staff interview, and review of facility contracts, the facility failed to ensure that in 100 % of patient deaths the individual who initiated the request for organ donation was a designated requestor. The findings were:

Review of the 6/16/11 letter from the facility's OPO revealed that a designated requestor did not initiate the request for organ donation for 2 patients who passed away in 2010. Further review of the letter showed that designated requestors were required to initiate 100% of the approaches. On 9/3/11 at 3:45 PM the, senior manager stated that not all staff were designated requestors. Interview with the case manager/clinical educator on 9/7/11 at 4:30 PM confirmed the statement. Review of the facility's 2011 contract with the OPO revealed that in the absence of a designated requestor, the OPO will be the designated requester

Based on patient interview, the facility failed to ensure privacy was maintained for 1 of 7 current sample patients (#3). The findings were:

Interview with patient #3 on 9/7/11 at 3:10 PM revealed s/he had a difficult time when a patient from another area was moved into his/her room on 9/6/11. The patient said the roommate had four family members (three were young children), who stayed in the room all night. The patient said there was no privacy curtain around his/her bed so when it was time to get ready for bed, s/he had no privacy. The patient asked staff for a privacy curtain and they brought one to the room; however, there were not enough hooks to hang it until the following day. The patient stated it was an uncomfortable situation for him/her.