Bringing transparency to federal inspections
Tag No.: A0273
Based on document review and interview, it was determined for 2 of 3 (Samples #1 and #3) randomly sampled Quality Assessment Performance Improvement (QAPI) projects and 1 of 1 (Adverse Event #1) adverse event in which a process was changed, the Hospital failed to ensure QAPI projects included the reason for the project, the scope of data collection method, the defined threshold for comparative measurement, the segregation of data, where applicable, and ongoing monitoring to assure corrective action(s) was/were effective and maintained. This has the potential to affect all patients serviced by the Hospital.
Findings include:
1. The "Performance Improvement Measurement Report" dated January 2015 thru March 2016 and "Ancillary Departments Performance Improvement Indicatiors" dated January 2016 thru April 2016 were reviewed on 6/8/16 at approximately 10:00 AM. The following were identified:
a. Sample #1 lacked segregation of data collected and defined threshold for comparative measurement.
b. Sample #3 lacked reason for project, scope of data collection method (number/percent to be completed per reporting period), and segregation of data.
c. Adverse Event #1 lacked establishment, implementation, and plan for ongoing monitoring of the corrective action(s) to assure if was/were effective and maintained.
2. An interview was conducted with the Director of Environmental Services (E#14) on 6/7/16 at approximately 3:30 PM. When asked how the QAPI results are obtained, reported, and what the desired threshold was, E#14 stated "We (the staff) do observations and I report how many we did and how many did not meet our expectation. Obviously, we want 100% to meet (our expectation), but we didn't set a certain number (threshold). We do the observations in various areas (units). I don't have a certain number that we do and I don't separate the number out (by unit being observed) but I can."
3. Adverse Event #1, dated April 2016, was reviewed on 6/9/16 at approximately 10:00 AM. The "Improvement Action Plan" stated "Opportunity to Improve... Admission search did not reveal blade (razor)" with an "Action... using metal detector to... Target Date For Implementation... immediately... and
Completion Date Intials... 5/3/16..." The form further stated "Measures" was blank and "Follow-up for Effectiveness: If results are not 90%..."
4 An interview was conducted with the Director of Quality Initiatives (E#2) on 6/9/16 at approximately 10:00 AM. E#2 stated "You won't see the reason for the projects. Some are required and others the departments have felt there was an area they could improve and wanted to do a project and did it (or are currently doing it).... (Sample #1) is for ACU (Advanced Care Unit), ED (Emergency Department), and Med/Surg (Medical Surgical). I don't separate them out like I do for Med Rec (Medication Reconciliation- Sample #2)... but I can... We don't have thresholds for all of them (the projects). We can see if it (the project) improves or not with each report and put whether it is better than the previous month or not..."
Tag No.: A0450
Based on document review and interview, it was determined in 2 of 30 (Pt's #1, #17) medical records reviewed, the Hospital failed to ensure all entries and/or orders were accurately authenticated, as per policy. This has the potential to affect all patients receiving services.
Findings include.
1. The "Medical Staff Rules and Regulations" (2016) were reviewed on 6/8/2016 at approximately 9:00 AM. The rules and regulations stated under, "II. Medical Records 7...
Verbal orders shall be signed before the member of Medical Staff leaves the area.... 8. All orders dictated over the telephone shall be signed by the appropriately authorized person.... Telephone orders shall be used sparingly and shall be countersigned with the date and time... within 72 hours of the telephone order."
2. The medical record of Pt #1 was reviewed on 6/6/16 at approximately 2:00 PM. Pt #1 was admitted to the Advanced Care Unit (ACU) on 1/27/16 with the diagnosis altered mental status. The "Restraints/Seclusion" orders written by the nurse for 1/27/16, 1/28/16, and 1/29/16 lacked the date and time the order was signed by the physician and lacked documentation indicating if the physician order was a telephone or verbal order.
An interview was conducted with the Director of Quality (E #2) on 6/8/16 at approximately 10:00 AM. E #2 stated "All records are to be timed and dated, and indicate whether a verbal or telephone order."
3. The medical record of Pt #17 was reviewed on 6/8/16 at approximately 1:00 PM.
Pt.# 17 was admitted to the Emergency Department (ED) on 5/25/16 with the chief complaint shortness of breath. On 5/25/16 between 8:13 PM to 8:14 PM, verbal orders were given for labwork: brain natriuretic peptide, complete blood count with automatic differential, complete metabolic panel, prothrombin time, protime/International Normalized Ratio, and troponin I. There were also verbal orders given for a portable chest x-ray and a 12-lead electrocardiogram. The verbal orders were signed by the physician on 5/27/16 at 8:12 PM and not before leaving the area.
An interview was conducted with the Emergency Director (E#12) on 6/9/16 at approximately 8:50 AM. E#12 reviewed Pt #17's record and verbally agreed Pt #17's verbal orders were not signed before the physician left the area.
Tag No.: A0505
Based on observation, staff interview, and document review it was determined the Hospital failed to ensure outdated drugs and/or biologicals were not available for patient use. This has the potential to affect all inpatients and outpatients receiving Hospital services.
Findings include:
1. On 6/6/16 at 2:30 PM, a tour of the family maternity services department with the Nurse Manager (E# 8) was conducted. In the cabinet located in the procedure room, one (1) opened multi-dose vial of Lidocaine labeled with the date of 3/25/16 was available for patient use.
An interview was conducted at the time of the tour on 6/7/16 at 2:30 PM with E#8 who observed the opened multi-dose vial. E#8 indicated the time frame for use after opening a multi-dose vial is 28-30 days and stated, "The vial should have been disposed within the 30 days."
2. On 6/7/16 at 9:15 AM, a tour of the medical surgical unit with the Nursing Coordinator (E#7) was conducted. In the medicine cabinet was one (1) opened multi-dose vial of Novolin R insulin without a label of date opened.
3. On 6/7/16 at 9:45 AM, a tour of the advanced care unit with E#7 was conducted. In the medicine cabinet was one (1) opened multi-dose vial of Humulog R insulin without a label of date opened.
On 6/7/16 at 10:00 AM, an interview was conducted with the Nursing Coordinator (E#7). E#7 observed the opened, unlabeled and undated vials on the medical surgical unit and on the advanced care unit. E#7 confirmed both vials of insulin should have had a label with date they were opened.
4. The Hospital policy dated, 4/1/15, titled, "Stability and Storage of Opened Products" was reviewed on 6/6/16. The policy under "PROCEDURE: Whenever a product is opened or accessed that can be used again, a "date opened" sticker or writing directly on the container the date of accessing that product is required." Under "1. ...Injectable Products:....Injectable vials for multiple use...use within 28 days".
5. On 6/7/16 at approximately 2:00 PM, a tour of the Pharmacy was conducted with the Interim Pharmacy Director (E#11) and the Staff Pharmacist (E#10). In the Pharmacy freezer was one 2 ml (milliliter) Tisseel Fibrin Sealant, expired 5/31/16.
An interview was conducted with E#10 on 6/7/16 at approximately 2:00 PM. E#10 observed the outdated Tisseel Fibrin Sealant and stated, "It should have been taken out of the freezer and restocked."
6. On 6/6/16 at approximately 11:30 AM, a tour of the Radiology Department was conducted with the Director of Quality Initiatives (E#2) and the Radiology Director (E#13). One aresol spray of Pain Ease (topical anesthetic) was in a cabinet with an expiration date of 4/16.
7. An interview was conducted with E#2 and E#13 who both agreed the Pain Ease should have been disposed at the end of the month (4/16).
8. On 6/7/16 at approximately 2:00 PM during a tour with Director of Physician Practices (E#1) and Director of Rehab (E#9), 12 Allevyn non adhesive dressings in the wound care room had an expiration of 09/15.
An interview was conducted with E#1 at the time of the tour. E#1 agreed the dressings should not be available for use and should have been returned to Central Supply or disposed.
9. The Hospital policy titled "Expired and Other Unusable Medications" (effective 04/01/15) was reviewed on 6/9/16 at approximately 10:00 AM. The policy indicates under Procedures 3. "Expired or unusable medications must be removed from active stock..." The policy lacked any discussion related to expired biologicals.
An interview was conducted with E#1 on 6/9/16 at approximately 10:00 AM. E#1 reviewed the Expired and Other Unusable Medications policy and verbally agreed it did not address expired biologicals. E#1 stated inability to find any policy that addressed expired biologicals.
Tag No.: A0620
Based on observation, staff interview, and document review it was determined the Hospital failed to ensure all dietary practices are followed per policy to ensure proper food storage and safety. This has the potential to affect all patients, staff and visitors receiving dietary services.
Findings include:
1. On 6/6/16 at 2:00 PM, a tour of the dietary department was conducted with the Director of Food and Nutrition Services (E #4) and Dietician (E#5). In the walk-in freezer 1 bag of sausage links and 1 bag of french fries were opened and unlabeled. In the food pantry 1 bag of a powdered substance was opended, undated and unlabeled.
2. On 6/6/16 at 1:30 PM, a tour of the psychiatric unit was conducted with the Director of Psychiatric services (E#6 ). In the patient refrigerator 24 - 4 ounce containers of juice were undated and unlabeled, no expiration date.
On 6/6/2016 at 1:30 PM, an interview was conducted with the Director of Psychiatric services (E #6). E #6 verbalized the juice should have an orange sticker indicating the expiration date.
3. The Hospital policy, dated 4/15, titled, "FOOD STORAGE was reviewed on 6/6/16. Under PROCEDURE: General Storage Policies 4. Cover, label and date all food storage items, Use the FIFO method for storing food."
On 6/6/16 at 2:30 PM, an interview was conducted with E #4 and E#5. E#4 and E#5 verbalized all foods are to be labeled with date of opening or expiration date.