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Based on document review and interview the facility failed to develop a hospital wide Quality Assessment Performance Improvement (QAPI) program that included all areas and departments of the hospital and that these areas collected data to monitor, track, trend and analyze to identify areas of improvement or areas of concern. The facility also failed to develop QAPI projects and set priority to identify areas of high, medium and low concern.

---the facility failed to develop an ongoing hospital wide Quality Assessment Performance Improvement (QAPI) program that collects, tracks and analyzes data (See A-273),
--- the facility failed to identify performance improvement opportunities and therefore failed to set priorities for improvement projects (See A-283)
---the facility failed to report medical errors as part of the Quality Assessment Performance Improvement (QAPI) program (See A-286),
--- the facility failed to develop a hospital wide Quality Assessment Performance Improvement program, therefore the facility failed to identify performance improvement projects (See A-297),
---the governing body failed to determine Quality Assessment Performance Improvement (QAPI) priorities and provide for an ongoing program (See A-309).

Based upon observation and interview the facility failed to provide and maintain adequate physical facilities for the safety and needs of the patients and was found not in substantial compliance with the requirements for participation in Medicare and/or Medicaid at 42 CFR Subpart 483.70(a), Life Safety from Fire, and the 2000 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC), Chapter 19 Existing Health Care. Findings include

See the individually and below cited K-tags dated July 1, 2014.

K-0018
K-0029
K-0050
K-0054
K-0062
K-0147
K-0211

Based on policy review and interview, the facility failed to develop a process for the timely resolution of a grievance resulting in the potential loss of rights to all patients being served by the facility. Findings include:

On 07/02/2014 at 1035 during review of the facility's grievance policy and procedure titled "Grievance Procedure, PolicyStat ID: 442446, Last Revised: 05/2013" reads in the section titled "Formal Complaint/Grievance:# 2. (bullet 6) Problem resolution and follow-up-The completed Patient Complaint/Grievance Form should be sent to Risk Management within five (5) working days where a written response detailing the nature and outcome of the investigation will then be sent to the complainant within 30 days."

On 07/02/2014 at 1040 during an interview with staff B (Director of Quality) when queried about the time frame being 30 days she stated "I thought that it was sooner than that." Staff B confirmed the findings in the policy and stated "It used to be different."
On 07/02/2014 at 1145 staff B produced the old facility policy that contained different and more timely responses to a complaint/grievance. Staff B stated, "We will need to incorporate these time frames into the new policy."

Based on document review and interview, the facility failed to develop a process for the prompt resolution of a grievance for 2 of 2 records reviewed (#10, #11) resulting in the potential loss of rights to all patients being served by the facility. Findings include:

On 07/02/2014 at 1000 during review of grievances filed and the hospital's process for resolution of the issue revealed the following:
Patient #10 filed a written grievance on "March 12, 2014" regarding issues with patient care while an inpatient. The hospital (Facility A) sent a letter on "March 17, 2014" that lacked information regarding the steps taken to investigate the grievance.

A grievance was filed (not dated or time stamped by hospital) by patient #11's spouse. The grievance address issues with care that her husband had received while a patient in the Emergency Department (ED) on "February 28th." The hospital had responded to the patient's spouse with a written response on March 17, 2014 stating, "I want to let you know we are investigating this thoroughly, and will be in contact with you within seven days."

On 07/02/2014 at 1030 during an interview with staff B (Director of Quality) when queried about any further documentation regarding correspondences with the patient's spouse, staff B stated, "This is all I could find, I can't find anything else that was sent to them."

Based on document review and interview, the facility failed to develop an ongoing hospital wide Quality Assessment Performance Improvement (QAPI) program that collects, tracks and analyzes data resulting in the potential for unidentified areas of needed improvement. Findings include:

On 07/03/2014 at 0800 during review of performance improvement information provided by staff B (Director of QAPI) revealed a lack of information regarding tracking and trending of quality improvement activities. Staff B provided a document titled, "Written Performance Review (WPR)-Staff, Evaluation Period" that contained a section titled "Performance Measures" and contained areas for documentation that read "Does Not Meet, Needs Improvement, Meets Expectations, Exceeds Expectations." A review of the document revealed that it was an employee evaluation tool not a quality document. Documents provided titled "Med (medical) Staff Quality Meeting Improvement Committee" revealed discussions only related to medical staff issues not hospital wide QAPI.
On 07/03/2014 at 1145 during an interview with staff B she confirmed that she was unable to locate any documentation of monitoring, tracking and trending of hospital wide activities related to QAPI.

Interview with staff B Director of Quality, on 07/03/2014 at approximately 10:00, revealed that the facility does not have a hospital wide QAPI program. There are bits and pieces of documentation from several departments but no formal hospital wide program involving all hospital department. Staff B was able to produce documents titled "Med (Medical) Staff Quality Meeting Improvement Committee" and "Patient Services Division Meeting Minutes" along with a dash board of some key areas being tracked. The dash board does not contain any tracking of medication errors, adverse events regarding falls or patient complaint or grievances.
Staff B verified that the governing body had not specified priorities for performance improvement. Staff B was unable to provide documentation of monthly meetings pertaining to hospital wide quality assessment performance improvement activities.

Based on interview the facility failed to identify performance improvement opportunities and therefore failed to set priorities of improvement projects. Findings include:

On 07/03/2014 at 1100 during an interview with staff B (Director of Quality), it was determined that the facility does not have an ongoing hospital wide quality assessment performance improvement program therefore there has not been any areas identified as high, medium or low priorities. Staff B stated, "I think that a lot of areas of the hospital look at different things but it is not put together as one complete program."

Based on document review and interview the facility failed to report medical errors as part of the Quality Assessment Performance Improvement (QAPI) program resulting in the potential for unidentified areas for improvement to prevent adverse patient events. Findings include:

On 07/03/2014 at 1000 during review of documentation provided by staff B related to QAPI activities revealed that the hospital does not have a hospital wide QAPI program. Documentation provided titled "Med Staff Quality Improvement Committee" for January 2014-June 2014 revealed that this committee does look at medication errors but not at any other medical errors that may or may not have occurred such as falls, near misses or staff injuries. The meeting minutes for January, February, March and April 2014 all reads "Subject-Medication Errors, Discussion-Reviewed and discussed. No trends were noted, Action-No issues identified." The documentation for the May meeting reads in the section titled Discussion-"Deferred not available from pharmacy. Pharmacy to provide March and April data at next meeting." The meeting data for June 2014 reads "Medication Errors, Discussion-Deferred not available from pharmacy, Action-Pharmacy to provide May data at next meeting."

On 07/03/2014 at 1100 during an interview with staff B (Director of Quality), when queried about the lack of medication errors being reported to the med staff meetings staff B stated, "I can not really speak to why it has not been reported, I do know that there have been some personnel changes in pharmacy."
It was further determined that due to a lack of hospital wide QAPI program staff B could not produce any further documentation of identifying, tracking or trending of any other types of medical errors that may occur at the facility.

Based on interview the facility failed to develop a hospital wide Quality Assessment Performance Improvement program, therefore the facility failed to identify performance improvement projects. Findings include:

On 07/02/2014 at 1500 a request was made of staff B for the documentation related to QAPI program. Staff B stated that she would gather it and have for review in the morning (07/03/2014). On 07/03/2014 at 0800 when staff B was asked again for the QAPI documentation staff B stated, "we do not have information put together in one program, we have bits and pieces from different places who do some monitoring in their own departments but not as a formal program." Staff B did produce some pieces of documentation such as "Med Staff Quality Meeting Improvement Committee" that address issues related to medical staff only. When asked if the hospital has a QAPI committee that included disciplines from different areas of the hospital staff B stated, "I have only been assigned this position for a short time but I don't believe they do."

Based on document review and interview, the governing body failed to determine Quality Assessment Performance Improvement (QAPI) priorities and provide for an ongoing program. Findings include:

On 07/03/2014 at 0800 during review of the performance improvement documentation provided by staff B (Director of QAPI) revealed that there was no documentation of priorities, data evaluations or an ongoing QAPI program. Interview with staff B Director of Quality, on 07/03/2014 at approximately 10:00, revealed that the facility does not have a hospital wide QAPI program. There are bits and pieces of documentation from several departments but no formal hospital wide program involving all hospital department. Staff B was able to produce documents titled "Med Staff Quality Meeting Improvement Committee" and "Patient Services Division Meeting Minutes" along with a dash board of some key areas being tracked. The dash board does not contain any tracking of medication errors, adverse events regarding falls or patient complaint or grievances.
Staff B verified that the governing body had not specified priorities for performance improvement. Staff B was unable to provide documentation of monthly meetings pertaining to hospital wide quality assessment performance improvement activities or a list of who the members are of the QAPI committee.

Based on record review and interview the facility failed to ensure that medications were administered for 2 of 2 patients (#16, #17) by an order from a physician resulting in the potential for patient harm for all patients being served by the facility. Findings include:

On 07/01/2014 at 1300 during review of the medical records for patients #15 and #16, revealed that the new born's had just been delivered on 07/01/2014 in the morning. The records contained a document titled "Newborn Nursery Orders." The documents contained a pre-typed set of orders that could be ordered by a physician. The documents located in the records for patient #15 and #16 both contained documentation by a nurse for noting the orders but did not contain documentation of who the physician was that ordered them. The documents did not contain any reference to the orders being initiated as signed orders by the physician in person at the time of delivery, as telephone orders, as verbal orders or as standing orders. The order set does contain documentation for the administration of Vitamin K and Erythromycin Ophthalmic Ointment to each eye.

On 07/01/2014 at 1330 during an interview with staff J (Registered Nurse) when queried about the orders lacking a physician's signature she stated, "I initiate the first six things on the order sheet before I ever call the Pediatrician." Staff J then stated, "I see what you mean though, we should have them as a standing order or call to get an order to initiate them."

Based on document review, policy review and interview, the facility failed to ensure that all patient medical records were completed within 30 days of discharge of the patient. Findings include:
On 07/01/14 at 1010 during document review it was determined that there were 111 incomplete medical records awaiting for physician documentation along with an additional 85 medical records that were incomplete from nursing services.
On 07/02/14 at 1400 during review of the document titled, "Rules and Regulations of the Medical Staff, dated 01/2011,#19-The patient's medical record shall be completed at time of discharge, including progress notes, final diagnosis and (dictated) clinical summary... If, after 14 days after being placed in the physician's box, the record is still incomplete, the physician will be notified in writing that his/hers privileges to admit patients shall be suspended two (2) days from the date of notice, and such practitioner shall remain suspended until the records have been completed."
On 07/03/14 at 1015 during an interview with staff C (Health Information Manager) confirmed the finding of 196 incomplete medical records greater than 30 days post discharge. When staff C was queried about physician suspension she stated, "there is only one physician out of seven delinquent, who was suspended."

Based on document review, interview and policy review the facility failed to ensure that staff keep accurate records for the disposition of all controlled substances. Findings include:

On 07/01/2014 at 1500 during review of controlled substance administration records dated June 2014, revealed that; staff do not always obtain a co-signature for the witnessing of waste, staff scribble out information on the logs, medication counts are not always accurate and staff are dividing and using vials of Fentanyl labeled for single patient use for more than one person.

Document titled, "Controlled Substance Administration Record" from the Emergency Department dated 6-1-14 contained information for the administration of Valium 5 mg (milligram) from a 10 mg carpuject. The document contained an area for "Co Sign for waste" of the unused 5 mg. That area contained only a circle and no signature.
Document titled, "Controlled Substance Administration Record" from "Anesthesia Room/Box #3 Blue" for 6-2-14 revealed a document that contained information for the administration of controlled substances to four patients. The documentation for the first two patients was for the administration of "0.2 cc" of Fentanyl from vials that contained 2 mls. The portion of document that contained an area for "waste" lacked documentation of the 0.8 mls waste for both of these patients and lacked witness co signatures for the waste. The document also contained two areas in the "waste" columns for the next two patients that had been scribbled out and were illegible.
Document titled, "Controlled Substance Administration Record" from "Anesthesia Room/Box #1 Blue" for 6-2-14 revealed that the document identified six patients that had received administration of one or more controlled substances. The document showed that at the start of the day 20 ml (10 vials) of Fentanyl was in Box #1. The second and fifth patient identified on the record received "1 ml" of Fentanyl. The record lacks a co signature for waste of the remaining 1 ml for both patients. The count at the end of the day was documented as 14 ml. The administration record reveals that the amount administered and the amount returned adds up to 20 ml revealing that the staff divided one single dose vial of Fentanyl between two patients.
Document titled, "Controlled Substance Administration Record" from "Anesthesia Room/Box #3 Blue" for 6-10-14 revealed that the document identified administration of Fentanyl to six patients. The total amount dispensed in the box at the beginning of the day was 20 ml. The documentation on the record accounts for administration of 11 mls total with no recorded waste. The returned amount at the end of the day was 8 ml revealing that there was 1 ml of Fentanyl unaccounted for.

On 07/02/2014 at 1100 during an interview with staff M (Director of Anesthesia), the above documents were reviewed and confirmed by staff M. Staff M stated, "these (administration records) are supposed to be filled in completely with the date and time of administration, dose given to the patient and the amount wasted and contain a co signature for waste." When queried about the Fentanyl count not adding up, staff M reviewed the document and stated, "no, it does not add up and I can't tell from this where it went." When queried further about dividing single dose vials of medications staff M stated, "I think that staff look at this as a cost saving measure." When asked if this is an acceptable practice staff M stated, "No, they are not supposed to do this."

On 07/02/2014 at 1115 during review of the facility's policy titled "Medication Distribution-Controlled Substances used in the Anesthesia/Surgical Department, PolicyStat ID: 254364, Last Revised: 12/2008" reads in section titled "Policy: 3. The anesthesia provider will accurately document all doses given to the patient on the sign out sheet for each box. Any wastage of controlled substances not used must also be documented and witnessed by a licensed professional (signature required). 4. A pharmacist will verify the accuracy of the signed out controlled substances and check the contents of the box to assure accountability for all remaining and used contents."
Review of a second policy titled "Infection Control/Safety Procedures-Medication Vial/Ampule Guidelines, PolicyStat ID: 254273, Last Revised 09/2010" reads in the section titled "Policy: 1. Single Dose Container-Single dose containers of medications will be used according to the manufacture's guidelines. Single dose containers are preservative-free and any medication in the container that is not used for the patient should be discarded after the container is opened..."

On 07/03/2014 at 1000 during an interview with staff N (Director of Pharmacy), when queried about the above findings staff N replied, "We have talked to staff before and told them that they are not allowed to use single dose vials of medications for more than one patient." When queried about the count inconsistency on the record staff N stated, "I was not aware that it did not add up." When queried if she understood that pharmacy was responsible for the accurate records for disposition of controlled substances staff N stated, "I am."

Based on observation, interview, and policy review, the facility failed to ensure that outdated medications and supplies are maintained at an acceptable level of safety and quality resulting in the potential for poor patient outcomes. Findings include:

On 07/01/14 at 1045, during tour of the Medical/Surgical Department, the following opened and undated supplies were found:

1-bottle of "High Control" solution for blood glucose monitoring.
1-bottle of "Low Control" solution for blood glucose monitoring.

On 07/01/14 at 1046 staff E confirmed that the bottles of solution for "High" and "Low" glucose monitoring were not properly labeled with an expiration date.

On 07/02/14 at 1345 during review of the policy titled, "Procedure Glucose" policy #010.710.102, dated 10/13, stated under the heading "Storage and Stability of Strips and Controls-The open expiration date must be written on each bottle when opened. (The solution is) Stable for 90 days after opening."


28273

On 07/01/2014 at 1030 during observation of the Emergency Department (ED) with staff H (Director of ED Services) revealed the following:
Fourteen (14) outdated (1/2014) culture swabs,
One bottle of glucometer test strips not dated when opened,
One bottle of glucometer control test solution-date when opened illegible,
One 10 ml vial of Dexamethasone outdated 6/28/14.

Staff H confirmed the findings during the observation. When queried about the outdated supplies staff H replied, "When we have a slow time, everyone checks for outdates, so really we are all responsible to ensure that they get checked."

Based on observation, interview, and policy review, the facility failed to ensure that outdated supplies are maintained at an acceptable level of safety and quality resulting in the potential for poor patient outcomes. Findings include:

On 07/03/14 at 1045, during tour of the Surgical Department, the following outdated supplies were found:
· 3 bottles of Hydrogen Peroxide that outdated on 04/14

On 07/03/14 at 1100 staff L confirmed that the bottles of Hydrogen Peroxide were outdated and available for patient use.

On 07/03/14 at 1105, during tour of the Anesthesia Preparation Room, located in the Surgical Department, the following outdated supplies were found:
· 4-spinal needles, 25 gauge, outdated 01/14
· 1-LMA (Laryngeal Mask Airway) size 1.0, outdated 04/14
· 1-LMA, size 1.5 outdated 03/14
· 1-Endotracheal tube (ET tube) size 4.5, outdated 02/14
· 2-ET tubes, size 4.5, outdated 01/14
· 1-ET tube,size 4.5, outdated 08/09
· 1-ET tube, size 4.0, outdated 12/13
· 1-ET tube (sterile), size 6.0, opened, placed back into clean stock.

On 07/03/14 at 1115 staff K confirmed that the supplies were outdated and available for patient use.

On 07/03/14 at 1345 during review of the policy titled "Expired Supplies, PolicyStat ID:463257, dated 09/2013" stated under the heading "Procedure- A) Each patient care area shall have a dedicated checklist for monthly inventory review for outdated, or deteriorated supplies. B) On the first of the month based on a scheduled staff rotation, inventory check will be assigned. C) Any item as being expired, will be removed from area and reordered/replaced."