HospitalInspections.org

See Tag C-0152 for additional information regarding compliance with the COP: Patient's Rights, 482.13 (a)(2)(iii).

Based on record review and interviews with key staff on November 20, 2013, it was determined that the facility failed to ensure that all patient care services were furnished in accordance with The Code of Maine Regulations.

Findings include:

1. The Code of Maine Regulations (C.M.R.), 10-144 C.M.R. 128 2.1 stated, "Before hiring an individual to work as a C.N.A., a health care institution, facility or organization, must, at a minimum, contact the Maine C.N.A. Registry to verify that the C.N.A. is on the list of active C.N.A.'s on the Registry and has no disqualifying annotations."

2. Review of the personnel file for four C.N.A.'s (Certified Nursing Assistant) indicated that C.N.A. (File O), had a date of hire of June 11, 2013.

3. Documentation in the personnel file for this C.N.A. indicated that the C.N.A. Registry was not contacted until June 17, 2013, six (6) days after the date of hire.

4. This finding was confirmed by Human Resources on November 20, 2013 at approximately 2:00 p.m.

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Based on review of the grievance log, review of five (5) grievances and interviews with the Director of Quality on November 20, 2013, it was determined that the facility failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, Section 3.2., which states that a critical access hospital must protect patient rights and comply with the Federal Condition of Participation: Patient's Rights 482.13(a)(2)(iii), which states that in the resolution of the grievance, the hospital must provided the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. Grievance A's letter dated May, 10, 2103, did not contain the results of the grievance process.

2. Grievance B's letter dated August 6, 2013, did not contain the results of the grievance process.

3. Grievance C's letter dated November 7, 2013, did not contain the results of the grievance process.

4. Grievance D's letter dated October 4, 2013, did not contain the results of the grievance process.

5. Grievance E's letter dated May 30, 2013, did not contain the steps taken to investigate the grievance or the results of the grievance process.

6. These findings were discussed with the Director of Quality on November 20, 2013, at approximately 5:30 p.m.

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32893

Based on observation of one (1) surgical procedure on November 21, 2013, at approximately 8:23 a.m., it was determined that the facility failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, Section 3.2., which states that a critical access hospital must protect patient rights and comply with the Federal Condition of Participation: Patient's Rights, 482.13(c)(2), which states, "The patient has the right to receive care in a safe setting."

Findings include:

1. In Operating Room 1 a staff member was observed to use a "Roller Board"[a device utilized in patient transfers] that had been stored on the operating room floor, in the transfer of a surgical patient from the operating room table to the stretcher.

2. Policy "SURGICAL SUITE" states, "Asepsis of the Surgical Suite instruments and equipment, along with proper surgical attire and performance of personnel, cannot be overemphasized."

3. This action exposed the patient to a high degree of risk for contamination by foreign substances and organisms and violated the patient's right to receive care in a safe setting.

Based on observations, record review and interview with key staff on November 19, 20, and 21, 2013, it was determined that the facility failed to assure all essential mechanical, electrical, and patient care equipment was maintained in safe operating condition.

Findings include:

1. On 11/20/2013, at 9:00 a.m., a surveyor observed that there was no air gap provided on the ice machine drain line to the waste water drain on the floor. This is a violation of the Uniform Plumbing Code, Chapter 22, August 2005, Chapter 8, Section 801.2.3, page 63. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 9:00 a.m.

2. On 11/20/2013, at 8:22 a.m., a surveyor observed that there was no air gap provided on the drain line to the waste water line of the vegetable sink. This is a violation of the Uniform Plumbing Code Chapter 22, August 2005, Chapter 8, Section 801.2.3, page 63. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:22 a.m.

3. On 11/20/2013, at 8:20 a.m., a surveyor observed that 8/2 dozen size muffins tins and 3/1 dozen size muffin tins were encrusted with a black baked on substance creating an uncleanable surface. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:20 a.m.

4. On 11/20/2013, at 8:30 a.m., a surveyor observed that the Teflon coating was chipped and peeling on two eight inch saute pans, creating the potential for a non-editable metal to be ingested. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:30 a.m.

5. On 11/20/2013, at 8:30 a.m., a surveyor observed that two ten inch saute pans were encrusted with a black baked on substance creating an uncleanable surface. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:30 a.m.

6. On 11/19/2013, at 1:45 p.m., a surveyor observed that the vaccine freezer located in the Lincoln Health Center Building contained a build up of ice. The build up of ice could cause the unit to overheat and malfunction and /or prevent the door from closing causing the product stored inside to become compromised. This finding was confirmed in an interview with the Maintenance Supervisor on 11/19/2013, at 1:45 p.m.

7. On 11/19/2013, at 2:40 p.m., a surveyor observed that there was a build up of ice in the freezer located in the Searsport Health Center. The build up of ice could cause the unit to overheat and malfunction and /or prevent the door from closing causing the product stored inside to become compromised. This finding was confirmed in an interview with the Maintenance Supervisor on 11/19/2013, at 2:40 p.m.

8. The surveyor observed all of the above findings being corrected November 19-21, 2013.

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30938

During a tour of the Emergency Department, the Medical/Surgical Unit and interviews with the Triage Nurse and the Medical/Surgical Unit Manager on November 19 and 21, 2013, it was determined that the facility failed to ensure the safety and well-being of patients by assuring that all patient care equipment was maintained in safe operating condition;

Findings include:

1) Treatment Room 1: Two (2) "3-way" stopcocks with expiration dates of "9/2011" and "9/2013" .

2) Treatment Room 8: Four (4) "Quick-Combo Pediatric Defibrillator Pads" with expiration dates of "7/28/13" (two (2) sets), "4/28/13" and "11/28/12" .

3) Treatment Room 9: Eight (8) sets "Gaymar Blood/Fluid Warmer infusion sets" with expiration of "09/2013 ".

4) These findings were confirmed with the Emergency Department Triage Nurse on November 19, 2013, at approximately 11:30 a.m.

5. During a tour of the Medical/Surgical Unit the following was observed in the rooms identified:

a. Cord type call bells in the bathrooms of rooms, 205, 206, 210, 211, 212, 213, 217, 218, 220, 221, 223, 225 and 227 were material based, and longer than five feet in length, which were all unable to be sanitized, and would trail along the floor if not tied to "grab bars". If tied to grab bars, it would negate the purpose of being available to reach the cord if a patient fell onto the floor and needed to call for help.

b. The call bell cords in the bathrooms of rooms 219 and 224, were between 12 and 16 inches and patients who fell onto the floor would not be to reach them to call for assistance.

6. The above findings were confirmed by the Medical/Surgical Unit Manager on November 21, 2013, at approximately 9:00 a.m.

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32893

Based on document review, observations and interviews with key staff, in the Surgical Services Department, on November 19, 2013, at approximately 1:30 p.m., it was determined that the facility failed to maintain all patient care equipment in safe operating condition.
Findings include:

1. In OR 2 one (1) stool had rusty casters.

2. In OR 3 two (2) stools had rusty casters.

3. In " Sub-sterile Room 3 " there were two stools with rusty casters. One of these stools also had a worn cushion that was unable to be sanitized.

4. In the " Sterile Hall " four (4) of four (4) " Yellow Fins " positioners had torn liners.

5. In the ASU multiple over bed tables had chipped and non-intact surfaces.

6. In Procedure Room 2:
a. One (1) missing floor tile behind the door.
b. One (1) basin stand with rusty castors.
c. One (1) wall mounted hand sanitizer dispenser was damaged and taped together.

7. These finding were immediately confirmed with the Perioperative Services Manager.

8. On November 20, 2013, at approximately 1:00 p.m., a survey of the above areas confirmed that the equipment noted above as having " rusty castors " had been removed from service.

Based on observations and interviews with key staff on November 19, 2013, it was determined that the facility failed to have housekeeping and preventive maintenance programs to ensure that drugs and biologicals were appropriately stored;

Findings include:

1. During a tour at the WCMP (Waldo County Medical Provider) Urology Clinic, approximately twenty (20) insulin syringes were observed in a drawer in the treatment room, with no lock on the drawer.

2. On 11/19/2013, at 1:48 p.m., a surveyor observed an open bottle of Sodium Chloride stored on a shelf in the exam room in the Lincolnville Regional Health Center. The product label stated to discard the unused portion.

3. These findings were confirmed by the Physician Services Manager on November 19, 2013, at approximately 10:00 a.m.

Based on review of the 2012 and 2013 Governing Body meeting minutes, the 2012 and 2013 WCHI Quality Assessment and Performance Improvement Program , the 2012 and 2013 Quality Assessment and Performance Improvement Committee meeting minutes, The Quality Assessment Performance Improvement Monthly Dashboards for June, July, August and September 2013, review of facility wide policies and procedures, review of inpatient and outpatient medical records, review of grievances, review of other information provided, and interviews with the Chief Executive Officer, the Chief Nursing Officer, Director of Operations, Director of Quality, Director, Medical Affairs, Emergency Department physicians, the Emergency Department Manager, on November 19-21, 2013, it was determined that the CAH's Governing Body failed to assume full legal responsibility for the CAH's total operation and failed to ensure the policies and procedures in place provided quality health care and safety for patients, staff and visitors in the hospitals as evidenced by:

1. The CAH's [Critical Access Hospital ' s] Governing Body failed to assume full legal responsibility and ensure the quality of patient care (See Tags C-0151, C-0152, C-0222, C-0224, C-0241, C-0276, C-0277, C-0307 and C-0336);

2. The CAH failed to ensure that all patient care services and other services affecting patient health and safety were evaluated (See Tags C-0330, C-0336 and C-0337);

3. The CAH failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes (See Tag C-0336);

4. The CAH ' s Governing Body failed to ensure that appropriate remedial action to address deficiencies found through the quality assurance program was taken (See Tag C-0335, C-0342, and C-0343); and

5. The CAH ' s Governing Body failed to assume full responsibility for determining, implementing, and monitoring policies, governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. (See Tags C-0224, C-0241, C-0276, C-0277 and C-0335).

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of policies and procedures, review of information provided and interviews with key staff on November 20, 2013, it was determined that the individual that assumed full legal responsibility for ensuring that policies were administered failed to ensure that the Restraint policy was followed.

Findings include:

1. Waldo County General Hospital policy titled ' Use of Restraints/Personal Protective Devices' stated, " 1. Physician Orders: ......Place a Restraint Orders label on the physician order sheet for each new 4 - hour episode of physical or chemical restraint use..."

2. Four (4) restraint records were reviewed on November 20, 2013, and two (2) of the four (4) records did not contain the physician order sheet with a Restraint Orders label attached.

3. This finding was confirmed by the Medical Records Director on November 20, 2103, at approximately 3 p.m. Additionally, the Director stated that she had spoken to another staff person and they had stated that the label only applied to physical restraints.

4. Please see Tags C-0276, C-0277 and C-0335 for additional information regarding policies not followed.


30938

5. See Tags C-0222 and C-0276 for additional information related to policies and procedures not being followed.

Based on review of the sample log at hospital clinics and interviews with key staff on November 19, 2013, it was determined that the facility failed to follow their own policy related to sample medications.

Findings include:

1. The Waldo County General Hospital policy titled, ' Medication Samples-Hospital Clinics and Physician's Offices', stated that it's purpose was, "To establish procedures for receipt, storage and distribution of medication samples at WCGH owned physician offices and clinics".

2. Review of the sample log at the Diabetes Clinic documented that the quantity received of Victoza was five (5). On September 17, 2013, quantity given out was one (1), and quantity left was five (5).

3. Review of the sample log at the Nephrology Clinic documented that the quantity received of Symbicort 80/4.5 was two (2). on November 1, 2013, one (1) was issued to a patient leaving one (1). Count on the shelf of the supply storage was two (2).

4. The above findings were confirmed by the Practice Manager of the specific clinics on November 19, 2013 at approximately 10:45 a.m.

5. The facility policy, 'Care of Opened Solutions, General Considerations, stated, "discard if not marked with date, time and initials," and also, "discard when expired per information on container".

6. The facility policy, 'Pharmacy IC Policy', directs that in the case of multi dose vials, "vials which have been opened longer than 30 days shall be returned to Pharmacy for proper disposal".

7. During tour of the following clinics, these observations were made:
a. In WCMP (Waldo County Medical Provider) Surgery; an open bottle of hydrogen peroxide was found with no date of opening on it.
b. In the Nephrology Practice, one (1) bottle of Triadine were found, one (1) with a manufacturers expiration date of January 2013, and one (1) with a manufacturers expiration date of October 2013.
c. In WCMP (Waldo County Medical Provider) Obstetrics, one (1) bottle of Triadine was found with an expiration date of July 2011, one (1) bottle of liquid sodium chloride with no date of opening, and one (1) package of Cidex OPA test strips, (used to test the solution used to sanitize the sonogram) with an expiration date of May 2011.
d. In the Diabetes Clinic, two (2) syringes with fluid were observed in the medication refrigerator with no label to identify the contents, one (1) bottle of influenza vaccine, was opened with no date of opening.
e. In the Searsport Clinic, an open vial of pneumovax was found in the medication refrigerator with no date of opening.

8. The above findings were confirmed by the Physician Practice Manager on November 19, 2013, at approximately 10:00 a.m.

9. In the medication room of the Medical Surgical Unit, an open vial of 1% lidocaine was observed with an expiration date of November 11, 2013. Also was a bottle of Iodine topical solution with an expiration date of September 2013, was found.

10. In the Soiled Utility room on the Intensive Care Unit, two (2) bottles of Chem Strip-9, used to "dip-stick" urine, had an expiration date of July 2013.

11. Both of the above findings were confirmed by the Medical/Surgical Unit Manager on November 21, 2013, at 9:10 a.m.

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30938


During a tour of the Emergency Department and interview with the Triage Nurse on November 19, 2013, at approximately 10:15 a.m.,and finishing the tour with the Emergency Department Nurse Manager November 20, 2013, at approximately 8:30 a.m., it was determined that the facility failed to follow their own policy related to opened solutions.


Findings include:

1) Waldo County General Hospital policy titled, 'Care of Opened Solutions' stated the following:
a) "Normal Saline and Sterile Water ...When opened, container must be marked with date, time, and initials of person opening it. Must be discarded after 24 hours."
b) "Solutions: Betadine, Alcohol & Hydrogen Peroxide ... These solutions are to be dispensed in small bottles, charges to the patient, and used as long as the patient is in the Hospital. The solution should then be discarded or sent home with the patient."
2) Treatment Room 1:
a) One (1) opened 16 ounce (oz) bottle Isopropyl Alcohol that was not marked with the time, date or initials when opened per hospital policy, and had an expiration date of "01/11" .
b) One (1) opened 1000 milliliter (ml) bottle sterile water that was not marked with the time, date or initials when opened per hospital policy.
c) Four (4) opened 4 oz povidone iodine (Betadine) bottles that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
d) Four (4) opened bottles Chlorhexidine 4% solution that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
3) Treatment Room 2
a) Three (3) opened bottles Chlorhexidine 4% solution that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
4) Hallway area in front of beds 3, 4, 5, and 6.
a) Two (2) opened 500 ml bottles sterile water that were not marked with the time, date or initials when opened per hospital policy.
b) In "bandaging cart" one (1) opened bottle Chlorhexidine 4% solution that was not marked with the time, date or initials when opened, or disposed of per hospital policy.
5) These findings were confirmed by the Emergency Department Triage Nurse on November 19, 2013, at approximately 11:00 a.m., and by the Emergency Department Nurse Manager on November 20, 2013, at approximately 8:45 a.m.

Based on review of policies and procedures, review of medical records and interviews with the Pharmacy Manager on November 20, 2013, it was determined that the facility failed to follow their procedures for reporting adverse drug reactions and errors in the administration of drugs, in five (5) of five (5) medical records. (RECORDS: UU, VV, WW, XX and YY)

Findings include:

1. Waldo County General Hospital policy titled, ' Medication Variances', stated, "3. b. Document in Department Progress Notes section of the daily Patient Care Documentation Form the name, dose and route of the medication ordered and the name, dose route of the medication given. Note any reactions and that the MD was notified."

2. Five (5) medical records were reviewed with the Pharmacy Manager on November 20, 2013. None of the five (5) medical records contained any documentation of errors in the administration of drugs and/or adverse drug reactions.

3. These findings were confirmed with the Pharmacy Manager on November 20, 2013 at approximately 3 p.m. The Manager stated that he did not know that the entry in the medical record was a requirement.

Based on record review, by-laws review and interviews with key staff on November 20, 2013, it was determined that the facility failed to assure that physician's orders were countersigned within 72 hours, in one (1) of twenty (20) medical records. (RECORD U)

Findings include:

1. The Medical Staff By-Laws, Rules and Regulations stated, "Physician verbal/telephone orders must be countersigned, dated and timed by the practitioner within seventy-two (72) hours."

2. The medical record of Patient U contained a V.O. (verbal order) dated November 11, 2013 at 2200. As of November 20, 2013, this V.O. had not been countersigned.

3. This finding was confirmed by the Charge Nurse on November 20, 2013, at approximately 1:30 p.m.

Based on review of Quality Assessment and Performance Improvement Committee Meeting minutes from October 16, 2013 - October 22, 2013, review of inpatient and out patient medical records, review of policies and procedures, review of Medical Staff Committee meeting minutes, review of the 2013 Waldo County General Hospital QAPI Dashboards for June - September 2013, review of the Waldo County General Hospital QAPI Plan, and interviews with key staff on November 19-21, 2013, it was determined that the CAH failed to ensure that the quality of the care and services provided at the facility were evaluated and data was collected to help identify any areas that needed improvement. The evidence is as follows:

1. The CAH failed to include in their periodic review of its total program, a review of a representative sample of both open and closed clinical records (See Tag C-0333);

2. The CAH failed to include in its total program evaluation if the established policies were followed and any changes needed (See Tag C-0335);

3. The CAH failed to ensure that there was an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the hospital (See Tag C-0336);

4. The CAH failed to ensure that the quality assurance program evaluated all patient care services and other services affecting patient health and safety (See Tag C-0337);

5. The CAH staff failed to consider the findings of the evaluation and take corrective action if necessary (See Tag C-0341);

6. The CAH failed to take appropriate remedial action to address deficiencies found through the quality assurance program (See Tag C-0342); and

7. The CAH failed to document the outcomes of all remedial action (See Tag C-0343).


The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of information provided and interviews with key staff on November 19 and 20, 2013, it was determined that the facility failed to include in their annual periodic evaluation, a review of a representative sample of both active and closed clinical records.

Findings include:

1. A review was conducted of the annual program evaluation on November 20, 2013. There was no documented evidence that a representative sample of both open and closed records had been reviewed.

2. It was confirmed by the Director of Quality on November 21, 2013 that there was no review of a representative sample of both opened and closed clinical records being done by the facility.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to determine whether the utilization of services was appropriate, the established policies were followed, and if any changes were needed.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any information regarding the utilization of services being appropriate, whether the established policies were followed, and if any changes were needed based on the review.

2. During an interview with the Director of Quality on November 20, 2013, he stated that there was no other information regarding the the annual program review in addition to what the surveyor had already reviewed.

Based on a review of documents as described below, along with interviews with key staff at the time of the survey, it was determined that the Waldo County General Hospital failed to have an effective quality assurance or performance improvement program to evaluate the quality and appropriateness of the care provided to its patients.

Findings include:

1. The Waldo County General Hospital Medical Staff QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PLAN - FY 2014 states " Purpose ...Measuring performance; analyzing outcomes; taking corrective action ...Demonstrating continuous improvement in patient outcomes ...Documenting processes related to quality improvement efforts ..." and, " SCOPE: All practitioners and all aspects of work which directly or indirectly effects patient care and promotes continual improvements in care and safety practices will be subject to inclusion in the Medical Staff Quality Assessment and Performance Improvement (QAPI) Plan.. " and, " Quality indicators: Indicators to assess and improve patient safety and outcomes ... "

2. During the Entrance Conference and again during meetings on November 19, 20 and 21, 2013, the Director of Performance Improvement and the Chief Medical Officer were asked to provide all evidence of medical staff performance improvement for the previous year, October 2012 through October 2013.

3. The Director of Performance Improvement said the list of Quality Improvement indicators for the prior year October 2012 through October 2013 were listed in Appendix A of the Medical Staff Quality plan.

4. Appendix A of the Medical Staff Quality Plan is titled, "LIST OF MEDICAL STAFF COMMITTEE SCREENING CRITERIA - 2014." The Appendix contains criteria for retrospective chart review and screening. There were no performance improvement goals or targets, or improvement indicators.

5. During a meeting on November 19, 2013, the Director of Performance Improvement said that Medical Staff Performance Improvement indicators were contained in the Dashboard titled, "Quality Assessment Performance Improvement Monthly Dashboard. "

6. The Director of Performance Improvement provided the " August Quality Assessment Performance Improvement Monthly Dashboard FY 2013 " for review. Quality Improvement indicators related to the medical care provided by the medical staff were either at their target or " not applicable " , with four exceptions. These exceptions were: " Aspirin at Arrival, Target 100%, Result Jun-13 - 50%, Comment, 2 Cases (1 Failed) Preprints Not Used " , " Prophylactic IV Antibiotic initiated within one hour prior to Surgical Incision, Target,100%, Result Jun-13 - 0%, Comment, 1 case: antibiotic not ordered/given " , " Median Time to ECG < 10 minutes, Target 100%, Result, 67%, Comment, 3 Cases (13 min, 1 failed) " , " Head CT scan results for acute ischemic or hemorrhagic stroke patients who received scan interpretation within 45 minutes of ED arrival, Target 100%, 50%, 2 cases (74 minutes, 1 failed) " . There was no evidence that the medical staff did any work to improve these indicators that did not achieve their targets with the exception of the work presented related to Troponin and CT/MRI as described below.

7. During an interview on November 19, 2013, the Manager of Performance Improvement said that with the exception of two projects, Head CT interpretation time and Troponin turn around time, the medical staff was not working on improving any of the performance measures on the dashboard.

8. On November 20, 2013, a meeting was held with representatives of the Medical Executive Committee to discuss Medical Staff Performance Improvement. Five physicians including the Chief Medical Officer were present. The physicians were asked to discuss Medical Staff Performance Improvement initiatives that involved measurable evidence of Performance Improvement.

9. The pediatric member of the Medical Executive Committee described an initiative to update the dose of Vitamin K given to newborns. He said that the dosage recommendations had changed, and the quality initiative was to update the dosage. The pediatrician stated that the policy change represented higher quality care since they were performing consistently with current national guidelines.

10. The minutes of the Perinatal Committee from July 2012 through October 2013 were reviewed. The minutes of the October meeting state, "Vitamin K Administration for Newborns. The Committee agreed to change the dosage from 0.5 mg IM to 1.0 mg which is the current recommendation by the American Academy of Pediatrics. Also, the policy has been changed to allow for Vitamin K to be given within "4 hours of delivery" as this would allow mothers and newborns uninterrupted time for initial breastfeeding and bonding." The minutes do not describe a process improvement initiative to measure the percentage of time that Vitamin K was given, nor was there any evidence that Vitamin K administration rates were below an established threshold, nor was there any evidence of plans to measure the results of this policy change.

11. There were no quality improvement initiatives related to the care of pregnant patients. This was confirmed by the Director of Performance Improvement and by the members of the Executive Committee.

12. During the meeting with the members of the Medical Executive Committee on November 20, 2013, the Emergency Physician representative stated that there are too many requirements from the Federal government, but did not describe any emergency physician performance improvement initiatives.

13. The Operating Room and Outpatient Procedures spreadsheet for 2013 was reviewed. The Surgeons at Waldo County General Hospital perform ENT, Ophthalmologic, Podiatric, Urologic, Gynecologic, Orthopedic and General Surgical cases in 2013. This includes major joint replacement, bowel resections, and other major surgeries confirmed by the Chief of Anesthesia who was interviewed during a meeting on November 20, 2013.

14. The Director of Performance Improvement was asked during meetings on November 20 and November 21, 2013, to provide evidence of quality improvement initiatives for surgery and the surgical specialties, involving quantitative measures of performance and to demonstrate improvement in physician performance. He said that would be found in the minutes of the endoscopy process Improvement Task Force. He provided minutes of the Endoscopy Process Improvement Task force.

15. The minutes of the Endoscopy Process Improvement Task Force were reviewed. The final meeting of this Task Force was August 15, 2010. No measurements related to the improvement of the quality or safety of endoscopic procedures were provided subsequent to 2010.

16. On November 21, 2013, the Director of Performance Improvement said the Surgical Champion of the Endoscopic Task Force would have additional information relevant to surgical quality.

17. During a meeting on November 21, 2013, the Surgical Champion of the Endoscopic Task Force was asked if there were any measurable improvement outcomes that he could produce relating to endoscopies and he said he did not have any data.

18. The Surgical Champion of the Endoscopic Task Force stated that the Chief of Surgery was away on vacation and was not available. He said they are using NSQIP, (National Surgical Quality Improvement Program), from the American College of Surgeons as their quality initiative. He described that they are in the process of entering their data and ensuring that the coding of the data is accurate and " statistically significant " . He said they have not used reports from the NSQIP database to initiate any process improvement initiatives.

19. During the interview on November 21, 2013, the Surgical Champion of the Endoscopic Task Force said he was a "Lean, Six Sigma Black Belt". He was asked if there were any quality improvement initiatives in surgery or the surgical specialties involving a quantitative assessment of performance along with initiatives to improve measurable performance. He answered, " No " .

20. The Chief Medical Officer said that the Waldo County Emergency Department sees 16,800 patients annually. He stated there were two Emergency Physician quality initiatives in 2013. These were " Troponin turn-around time " , and " Head CT or MRI scan results for Acute Ischemic Stroke or Hemorrhagic Stroke Interpretation within 45 minutes of ED arrival". He could not describe that these initiatives involved any change in emergency physician performance.

21. The Director of Performance Improvement provided the Troponin turn-around time " PDSA Cycle Worksheet " for review. This worksheet describes the project as, " Plan ...Laboratory Turnaround times for Troponin should be under one hour."

22. The minutes of the Troponin turn around time project document meetings to decrease laboratory turn around time. There was no evidence in these minutes of any initiatives relating to improving the care of patients by emergency physicians.

23. The second Emergency Department PDSA Cycle Worksheet presented was the Head CT or MRI scan results for Acute Ischemic Stroke or Hemorrhagic Stroke Interpretation within 45 minutes of ED arrival". The only times recorded in this study were the arrival time and time the CT/MRI results were interpreted by the radiologist. No evidence was presented that the care provided by emergency physicians was included in this project.

24. A review of the " Quality Assessment Performance Improvement Peri-Operative Services " Plan for the fourth quarter of 2012 and first through fourth quarters of 2013, failed to contain effective improvement data for selected indicators as exampled by the following:
Indicator = " Patients will have a SPO2 ? 92% upon arrival to PACU "
Goal for 4th QTR FY 2012 and 1st through 4th QTR FY 2013 is " 100% " . None of these reported quarters have achieved the 100% goal.
Both the " Prior Results " and Current Results " column header state: " ... had a SPO2 of 92% or less on arrival to Recovery Room " .
The PACU "Improvement Plan" for " 4th QTR FY 2012 " and " 1st QTR FY 2013 " states: " Numbers will be reported to anesthesia. Continue to monitor "
The PACU "Improvement Plan" for " 2nd QTR FY 2013 " states: " Continue to monitor to ensure there are no marked discrepancies in trends. "
The PACU "Improvement Plan " for " 3nd QTR FY 2013 " and " 4th QTR FY 2013 " states: " Communication of data to providers involved in patient care."

25. The " ACA " Indicator " Patients who respond that their pain was controlled ' always ' in follow up phone call " failed to have a Goal indicated for the fourth quarter of 2012 and first through fourth quarters of 2013, and contained no reported data for first through fourth quarters of 2013.

26. Both indicators for the " Perioperative " Unit failed to contain data for the Fourth Quarter 2013 (July-September 2013).

27. These findings were confirmed by the Perioperative Services Manager on November 20, 2013, at approximately 2:00 p.m.

28. Review of the Medical/Surgical program for Quality Assurance and Performance Improvement (QAPI) indicated that there was no data collected since April 2013.

29. The above finding was confirmed by the Medical/Surgical Nurse Manager, on November 21, 2013, at 10:20 a.m., who stated, "we haven't been monitoring quality since the April 2013 review".

30. Review of the QAPI plans for the Outpatient Clinics indicted that for each of the clinics with an indicator, after review of results, each "improvement plan", indicated, "to continue with monitoring".

31. The Pulmonology Clinic had two indicators, with a goal of 90% for each. When the indicators did not achieve their target, the plan was to "review records to verify Spiro done within 12 months", each quarter."

32. The Foot & Ankle Clinic had two indicators, one clinical and one safety. When the clinical indicator achieved its goal for three consecutive quarters, there was no evidence that a new clinical indicators were developed. The Safety indicator was " all patients who are provided patient education handouts will have it documented in the office notes". When the clinic failed to achieve sustainable improvement in any quarter, there was no evidence of actions taken to achieve improvement.

33. Gynecological and Obstetrical Services had two indicators, 1. Percentage of pregnant patients who received cystic fibrosis counseling, and documentation of number of interested patients who take cystic fibrosis test kit, and 2. Percentage of patients receiving pre-op counseling explaining risks and benefits of surgery in the office. The first and second indicators had a goal of 100%. Despite the lack of improvement over 4 quarters, the plan was "continue to document in chart".

34. The Cardiovascular Services had five indicators and the improvement plan for all five was continue to monitor for all four quarters.

35. Surgical Services had two indicators and the improvement plans for all four quarters were "to continue with monitoring" for one and "collecting data for next reporting period" for the other, if they reached their goal or not during each quarter.

36. Diabetes Services had two indicators and they were, review for a lipid profile, and review for annual eye exam. For both indicators during all three quarters (for those that did not have an update), the plan was "these charts have been flagged to check for the lipid panel at the next clinic." There was no indication of if they did the next quarter. There were no goals set for either indicator.

37. The Searsport Health Center had two indicators, with an improvement plan for the first of "continue to monitor" and the second indicator was changed in the third reporting quarter with no documentation to explain the change.

38. The above findings were confirmed by the Physician Services Manager on November 21, 2013, at approximately 2:30 p.m.

39. While Obstetrics, Surgery, Emergency Medicine, Medical/Surgical Inpatients and Outpatient Clinic patients represent high risk and high volume practices at Waldo County General Hospital, the hospital failed to document meaningful performance improvement initiatives in these key areas of patient care.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes and evaluate all patient care services and other services affecting patient health and safety.


Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding the evaluation of the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes or the evaluation of all patient care services and other services affecting patient health and safety.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to consider the findings of the evaluation, including any findings or recommendations of the QIO, and take corrective action if necessary.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding the findings of the evaluations, including any findings or recommendations of the QIO, and/or any corrective actions if necessary.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.

3. Please see Tag C-0336 for additional information regarding the quality assurance program.

Based on review of the Waldo County General Hospital 2013 Annual Program Review Critical Assess Hospital FY 2013, on November 20, 2013, it was determined that the facility failed to take appropriate remedial action to address all deficiencies found through the quality assurance program.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding taking appropriate remedial action to address all deficiencies found through the quality assurance program.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.

See Tag C-0152 for additional information regarding compliance with the COP: Patient's Rights, 482.13 (a)(2)(iii).

Based on record review and interviews with key staff on November 20, 2013, it was determined that the facility failed to ensure that all patient care services were furnished in accordance with The Code of Maine Regulations.

Findings include:

1. The Code of Maine Regulations (C.M.R.), 10-144 C.M.R. 128 2.1 stated, "Before hiring an individual to work as a C.N.A., a health care institution, facility or organization, must, at a minimum, contact the Maine C.N.A. Registry to verify that the C.N.A. is on the list of active C.N.A.'s on the Registry and has no disqualifying annotations."

2. Review of the personnel file for four C.N.A.'s (Certified Nursing Assistant) indicated that C.N.A. (File O), had a date of hire of June 11, 2013.

3. Documentation in the personnel file for this C.N.A. indicated that the C.N.A. Registry was not contacted until June 17, 2013, six (6) days after the date of hire.

4. This finding was confirmed by Human Resources on November 20, 2013 at approximately 2:00 p.m.

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Based on review of the grievance log, review of five (5) grievances and interviews with the Director of Quality on November 20, 2013, it was determined that the facility failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, Section 3.2., which states that a critical access hospital must protect patient rights and comply with the Federal Condition of Participation: Patient's Rights 482.13(a)(2)(iii), which states that in the resolution of the grievance, the hospital must provided the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. Grievance A's letter dated May, 10, 2103, did not contain the results of the grievance process.

2. Grievance B's letter dated August 6, 2013, did not contain the results of the grievance process.

3. Grievance C's letter dated November 7, 2013, did not contain the results of the grievance process.

4. Grievance D's letter dated October 4, 2013, did not contain the results of the grievance process.

5. Grievance E's letter dated May 30, 2013, did not contain the steps taken to investigate the grievance or the results of the grievance process.

6. These findings were discussed with the Director of Quality on November 20, 2013, at approximately 5:30 p.m.

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32893

Based on observation of one (1) surgical procedure on November 21, 2013, at approximately 8:23 a.m., it was determined that the facility failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, Section 3.2., which states that a critical access hospital must protect patient rights and comply with the Federal Condition of Participation: Patient's Rights, 482.13(c)(2), which states, "The patient has the right to receive care in a safe setting."

Findings include:

1. In Operating Room 1 a staff member was observed to use a "Roller Board"[a device utilized in patient transfers] that had been stored on the operating room floor, in the transfer of a surgical patient from the operating room table to the stretcher.

2. Policy "SURGICAL SUITE" states, "Asepsis of the Surgical Suite instruments and equipment, along with proper surgical attire and performance of personnel, cannot be overemphasized."

3. This action exposed the patient to a high degree of risk for contamination by foreign substances and organisms and violated the patient's right to receive care in a safe setting.

Based on observations, record review and interview with key staff on November 19, 20, and 21, 2013, it was determined that the facility failed to assure all essential mechanical, electrical, and patient care equipment was maintained in safe operating condition.

Findings include:

1. On 11/20/2013, at 9:00 a.m., a surveyor observed that there was no air gap provided on the ice machine drain line to the waste water drain on the floor. This is a violation of the Uniform Plumbing Code, Chapter 22, August 2005, Chapter 8, Section 801.2.3, page 63. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 9:00 a.m.

2. On 11/20/2013, at 8:22 a.m., a surveyor observed that there was no air gap provided on the drain line to the waste water line of the vegetable sink. This is a violation of the Uniform Plumbing Code Chapter 22, August 2005, Chapter 8, Section 801.2.3, page 63. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:22 a.m.

3. On 11/20/2013, at 8:20 a.m., a surveyor observed that 8/2 dozen size muffins tins and 3/1 dozen size muffin tins were encrusted with a black baked on substance creating an uncleanable surface. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:20 a.m.

4. On 11/20/2013, at 8:30 a.m., a surveyor observed that the Teflon coating was chipped and peeling on two eight inch saute pans, creating the potential for a non-editable metal to be ingested. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:30 a.m.

5. On 11/20/2013, at 8:30 a.m., a surveyor observed that two ten inch saute pans were encrusted with a black baked on substance creating an uncleanable surface. This finding was confirmed in an interview with the Dietary Manager on 11/20/2013, at 8:30 a.m.

6. On 11/19/2013, at 1:45 p.m., a surveyor observed that the vaccine freezer located in the Lincoln Health Center Building contained a build up of ice. The build up of ice could cause the unit to overheat and malfunction and /or prevent the door from closing causing the product stored inside to become compromised. This finding was confirmed in an interview with the Maintenance Supervisor on 11/19/2013, at 1:45 p.m.

7. On 11/19/2013, at 2:40 p.m., a surveyor observed that there was a build up of ice in the freezer located in the Searsport Health Center. The build up of ice could cause the unit to overheat and malfunction and /or prevent the door from closing causing the product stored inside to become compromised. This finding was confirmed in an interview with the Maintenance Supervisor on 11/19/2013, at 2:40 p.m.

8. The surveyor observed all of the above findings being corrected November 19-21, 2013.

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30938

During a tour of the Emergency Department, the Medical/Surgical Unit and interviews with the Triage Nurse and the Medical/Surgical Unit Manager on November 19 and 21, 2013, it was determined that the facility failed to ensure the safety and well-being of patients by assuring that all patient care equipment was maintained in safe operating condition;

Findings include:

1) Treatment Room 1: Two (2) "3-way" stopcocks with expiration dates of "9/2011" and "9/2013" .

2) Treatment Room 8: Four (4) "Quick-Combo Pediatric Defibrillator Pads" with expiration dates of "7/28/13" (two (2) sets), "4/28/13" and "11/28/12" .

3) Treatment Room 9: Eight (8) sets "Gaymar Blood/Fluid Warmer infusion sets" with expiration of "09/2013 ".

4) These findings were confirmed with the Emergency Department Triage Nurse on November 19, 2013, at approximately 11:30 a.m.

5. During a tour of the Medical/Surgical Unit the following was observed in the rooms identified:

a. Cord type call bells in the bathrooms of rooms, 205, 206, 210, 211, 212, 213, 217, 218, 220, 221, 223, 225 and 227 were material based, and longer than five feet in length, which were all unable to be sanitized, and would trail along the floor if not tied to "grab bars". If tied to grab bars, it would negate the purpose of being available to reach the cord if a patient fell onto the floor and needed to call for help.

b. The call bell cords in the bathrooms of rooms 219 and 224, were between 12 and 16 inches and patients who fell onto the floor would not be to reach them to call for assistance.

6. The above findings were confirmed by the Medical/Surgical Unit Manager on November 21, 2013, at approximately 9:00 a.m.

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32893

Based on document review, observations and interviews with key staff, in the Surgical Services Department, on November 19, 2013, at approximately 1:30 p.m., it was determined that the facility failed to maintain all patient care equipment in safe operating condition.
Findings include:

1. In OR 2 one (1) stool had rusty casters.

2. In OR 3 two (2) stools had rusty casters.

3. In " Sub-sterile Room 3 " there were two stools with rusty casters. One of these stools also had a worn cushion that was unable to be sanitized.

4. In the " Sterile Hall " four (4) of four (4) " Yellow Fins " positioners had torn liners.

5. In the ASU multiple over bed tables had chipped and non-intact surfaces.

6. In Procedure Room 2:
a. One (1) missing floor tile behind the door.
b. One (1) basin stand with rusty castors.
c. One (1) wall mounted hand sanitizer dispenser was damaged and taped together.

7. These finding were immediately confirmed with the Perioperative Services Manager.

8. On November 20, 2013, at approximately 1:00 p.m., a survey of the above areas confirmed that the equipment noted above as having " rusty castors " had been removed from service.

Based on observations and interviews with key staff on November 19, 2013, it was determined that the facility failed to have housekeeping and preventive maintenance programs to ensure that drugs and biologicals were appropriately stored;

Findings include:

1. During a tour at the WCMP (Waldo County Medical Provider) Urology Clinic, approximately twenty (20) insulin syringes were observed in a drawer in the treatment room, with no lock on the drawer.

2. On 11/19/2013, at 1:48 p.m., a surveyor observed an open bottle of Sodium Chloride stored on a shelf in the exam room in the Lincolnville Regional Health Center. The product label stated to discard the unused portion.

3. These findings were confirmed by the Physician Services Manager on November 19, 2013, at approximately 10:00 a.m.

Based on review of the 2012 and 2013 Governing Body meeting minutes, the 2012 and 2013 WCHI Quality Assessment and Performance Improvement Program , the 2012 and 2013 Quality Assessment and Performance Improvement Committee meeting minutes, The Quality Assessment Performance Improvement Monthly Dashboards for June, July, August and September 2013, review of facility wide policies and procedures, review of inpatient and outpatient medical records, review of grievances, review of other information provided, and interviews with the Chief Executive Officer, the Chief Nursing Officer, Director of Operations, Director of Quality, Director, Medical Affairs, Emergency Department physicians, the Emergency Department Manager, on November 19-21, 2013, it was determined that the CAH's Governing Body failed to assume full legal responsibility for the CAH's total operation and failed to ensure the policies and procedures in place provided quality health care and safety for patients, staff and visitors in the hospitals as evidenced by:

1. The CAH's [Critical Access Hospital ' s] Governing Body failed to assume full legal responsibility and ensure the quality of patient care (See Tags C-0151, C-0152, C-0222, C-0224, C-0241, C-0276, C-0277, C-0307 and C-0336);

2. The CAH failed to ensure that all patient care services and other services affecting patient health and safety were evaluated (See Tags C-0330, C-0336 and C-0337);

3. The CAH failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes (See Tag C-0336);

4. The CAH ' s Governing Body failed to ensure that appropriate remedial action to address deficiencies found through the quality assurance program was taken (See Tag C-0335, C-0342, and C-0343); and

5. The CAH ' s Governing Body failed to assume full responsibility for determining, implementing, and monitoring policies, governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. (See Tags C-0224, C-0241, C-0276, C-0277 and C-0335).

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of policies and procedures, review of information provided and interviews with key staff on November 20, 2013, it was determined that the individual that assumed full legal responsibility for ensuring that policies were administered failed to ensure that the Restraint policy was followed.

Findings include:

1. Waldo County General Hospital policy titled ' Use of Restraints/Personal Protective Devices' stated, " 1. Physician Orders: ......Place a Restraint Orders label on the physician order sheet for each new 4 - hour episode of physical or chemical restraint use..."

2. Four (4) restraint records were reviewed on November 20, 2013, and two (2) of the four (4) records did not contain the physician order sheet with a Restraint Orders label attached.

3. This finding was confirmed by the Medical Records Director on November 20, 2103, at approximately 3 p.m. Additionally, the Director stated that she had spoken to another staff person and they had stated that the label only applied to physical restraints.

4. Please see Tags C-0276, C-0277 and C-0335 for additional information regarding policies not followed.


30938

5. See Tags C-0222 and C-0276 for additional information related to policies and procedures not being followed.

Based on review of the sample log at hospital clinics and interviews with key staff on November 19, 2013, it was determined that the facility failed to follow their own policy related to sample medications.

Findings include:

1. The Waldo County General Hospital policy titled, ' Medication Samples-Hospital Clinics and Physician's Offices', stated that it's purpose was, "To establish procedures for receipt, storage and distribution of medication samples at WCGH owned physician offices and clinics".

2. Review of the sample log at the Diabetes Clinic documented that the quantity received of Victoza was five (5). On September 17, 2013, quantity given out was one (1), and quantity left was five (5).

3. Review of the sample log at the Nephrology Clinic documented that the quantity received of Symbicort 80/4.5 was two (2). on November 1, 2013, one (1) was issued to a patient leaving one (1). Count on the shelf of the supply storage was two (2).

4. The above findings were confirmed by the Practice Manager of the specific clinics on November 19, 2013 at approximately 10:45 a.m.

5. The facility policy, 'Care of Opened Solutions, General Considerations, stated, "discard if not marked with date, time and initials," and also, "discard when expired per information on container".

6. The facility policy, 'Pharmacy IC Policy', directs that in the case of multi dose vials, "vials which have been opened longer than 30 days shall be returned to Pharmacy for proper disposal".

7. During tour of the following clinics, these observations were made:
a. In WCMP (Waldo County Medical Provider) Surgery; an open bottle of hydrogen peroxide was found with no date of opening on it.
b. In the Nephrology Practice, one (1) bottle of Triadine were found, one (1) with a manufacturers expiration date of January 2013, and one (1) with a manufacturers expiration date of October 2013.
c. In WCMP (Waldo County Medical Provider) Obstetrics, one (1) bottle of Triadine was found with an expiration date of July 2011, one (1) bottle of liquid sodium chloride with no date of opening, and one (1) package of Cidex OPA test strips, (used to test the solution used to sanitize the sonogram) with an expiration date of May 2011.
d. In the Diabetes Clinic, two (2) syringes with fluid were observed in the medication refrigerator with no label to identify the contents, one (1) bottle of influenza vaccine, was opened with no date of opening.
e. In the Searsport Clinic, an open vial of pneumovax was found in the medication refrigerator with no date of opening.

8. The above findings were confirmed by the Physician Practice Manager on November 19, 2013, at approximately 10:00 a.m.

9. In the medication room of the Medical Surgical Unit, an open vial of 1% lidocaine was observed with an expiration date of November 11, 2013. Also was a bottle of Iodine topical solution with an expiration date of September 2013, was found.

10. In the Soiled Utility room on the Intensive Care Unit, two (2) bottles of Chem Strip-9, used to "dip-stick" urine, had an expiration date of July 2013.

11. Both of the above findings were confirmed by the Medical/Surgical Unit Manager on November 21, 2013, at 9:10 a.m.

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30938


During a tour of the Emergency Department and interview with the Triage Nurse on November 19, 2013, at approximately 10:15 a.m.,and finishing the tour with the Emergency Department Nurse Manager November 20, 2013, at approximately 8:30 a.m., it was determined that the facility failed to follow their own policy related to opened solutions.


Findings include:

1) Waldo County General Hospital policy titled, 'Care of Opened Solutions' stated the following:
a) "Normal Saline and Sterile Water ...When opened, container must be marked with date, time, and initials of person opening it. Must be discarded after 24 hours."
b) "Solutions: Betadine, Alcohol & Hydrogen Peroxide ... These solutions are to be dispensed in small bottles, charges to the patient, and used as long as the patient is in the Hospital. The solution should then be discarded or sent home with the patient."
2) Treatment Room 1:
a) One (1) opened 16 ounce (oz) bottle Isopropyl Alcohol that was not marked with the time, date or initials when opened per hospital policy, and had an expiration date of "01/11" .
b) One (1) opened 1000 milliliter (ml) bottle sterile water that was not marked with the time, date or initials when opened per hospital policy.
c) Four (4) opened 4 oz povidone iodine (Betadine) bottles that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
d) Four (4) opened bottles Chlorhexidine 4% solution that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
3) Treatment Room 2
a) Three (3) opened bottles Chlorhexidine 4% solution that were not marked with the time, date or initials when opened, or disposed of per hospital policy.
4) Hallway area in front of beds 3, 4, 5, and 6.
a) Two (2) opened 500 ml bottles sterile water that were not marked with the time, date or initials when opened per hospital policy.
b) In "bandaging cart" one (1) opened bottle Chlorhexidine 4% solution that was not marked with the time, date or initials when opened, or disposed of per hospital policy.
5) These findings were confirmed by the Emergency Department Triage Nurse on November 19, 2013, at approximately 11:00 a.m., and by the Emergency Department Nurse Manager on November 20, 2013, at approximately 8:45 a.m.

Based on review of policies and procedures, review of medical records and interviews with the Pharmacy Manager on November 20, 2013, it was determined that the facility failed to follow their procedures for reporting adverse drug reactions and errors in the administration of drugs, in five (5) of five (5) medical records. (RECORDS: UU, VV, WW, XX and YY)

Findings include:

1. Waldo County General Hospital policy titled, ' Medication Variances', stated, "3. b. Document in Department Progress Notes section of the daily Patient Care Documentation Form the name, dose and route of the medication ordered and the name, dose route of the medication given. Note any reactions and that the MD was notified."

2. Five (5) medical records were reviewed with the Pharmacy Manager on November 20, 2013. None of the five (5) medical records contained any documentation of errors in the administration of drugs and/or adverse drug reactions.

3. These findings were confirmed with the Pharmacy Manager on November 20, 2013 at approximately 3 p.m. The Manager stated that he did not know that the entry in the medical record was a requirement.

Based on record review, by-laws review and interviews with key staff on November 20, 2013, it was determined that the facility failed to assure that physician's orders were countersigned within 72 hours, in one (1) of twenty (20) medical records. (RECORD U)

Findings include:

1. The Medical Staff By-Laws, Rules and Regulations stated, "Physician verbal/telephone orders must be countersigned, dated and timed by the practitioner within seventy-two (72) hours."

2. The medical record of Patient U contained a V.O. (verbal order) dated November 11, 2013 at 2200. As of November 20, 2013, this V.O. had not been countersigned.

3. This finding was confirmed by the Charge Nurse on November 20, 2013, at approximately 1:30 p.m.

Based on review of Quality Assessment and Performance Improvement Committee Meeting minutes from October 16, 2013 - October 22, 2013, review of inpatient and out patient medical records, review of policies and procedures, review of Medical Staff Committee meeting minutes, review of the 2013 Waldo County General Hospital QAPI Dashboards for June - September 2013, review of the Waldo County General Hospital QAPI Plan, and interviews with key staff on November 19-21, 2013, it was determined that the CAH failed to ensure that the quality of the care and services provided at the facility were evaluated and data was collected to help identify any areas that needed improvement. The evidence is as follows:

1. The CAH failed to include in their periodic review of its total program, a review of a representative sample of both open and closed clinical records (See Tag C-0333);

2. The CAH failed to include in its total program evaluation if the established policies were followed and any changes needed (See Tag C-0335);

3. The CAH failed to ensure that there was an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the hospital (See Tag C-0336);

4. The CAH failed to ensure that the quality assurance program evaluated all patient care services and other services affecting patient health and safety (See Tag C-0337);

5. The CAH staff failed to consider the findings of the evaluation and take corrective action if necessary (See Tag C-0341);

6. The CAH failed to take appropriate remedial action to address deficiencies found through the quality assurance program (See Tag C-0342); and

7. The CAH failed to document the outcomes of all remedial action (See Tag C-0343).


The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on review of information provided and interviews with key staff on November 19 and 20, 2013, it was determined that the facility failed to include in their annual periodic evaluation, a review of a representative sample of both active and closed clinical records.

Findings include:

1. A review was conducted of the annual program evaluation on November 20, 2013. There was no documented evidence that a representative sample of both open and closed records had been reviewed.

2. It was confirmed by the Director of Quality on November 21, 2013 that there was no review of a representative sample of both opened and closed clinical records being done by the facility.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to determine whether the utilization of services was appropriate, the established policies were followed, and if any changes were needed.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any information regarding the utilization of services being appropriate, whether the established policies were followed, and if any changes were needed based on the review.

2. During an interview with the Director of Quality on November 20, 2013, he stated that there was no other information regarding the the annual program review in addition to what the surveyor had already reviewed.

Based on a review of documents as described below, along with interviews with key staff at the time of the survey, it was determined that the Waldo County General Hospital failed to have an effective quality assurance or performance improvement program to evaluate the quality and appropriateness of the care provided to its patients.

Findings include:

1. The Waldo County General Hospital Medical Staff QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PLAN - FY 2014 states " Purpose ...Measuring performance; analyzing outcomes; taking corrective action ...Demonstrating continuous improvement in patient outcomes ...Documenting processes related to quality improvement efforts ..." and, " SCOPE: All practitioners and all aspects of work which directly or indirectly effects patient care and promotes continual improvements in care and safety practices will be subject to inclusion in the Medical Staff Quality Assessment and Performance Improvement (QAPI) Plan.. " and, " Quality indicators: Indicators to assess and improve patient safety and outcomes ... "

2. During the Entrance Conference and again during meetings on November 19, 20 and 21, 2013, the Director of Performance Improvement and the Chief Medical Officer were asked to provide all evidence of medical staff performance improvement for the previous year, October 2012 through October 2013.

3. The Director of Performance Improvement said the list of Quality Improvement indicators for the prior year October 2012 through October 2013 were listed in Appendix A of the Medical Staff Quality plan.

4. Appendix A of the Medical Staff Quality Plan is titled, "LIST OF MEDICAL STAFF COMMITTEE SCREENING CRITERIA - 2014." The Appendix contains criteria for retrospective chart review and screening. There were no performance improvement goals or targets, or improvement indicators.

5. During a meeting on November 19, 2013, the Director of Performance Improvement said that Medical Staff Performance Improvement indicators were contained in the Dashboard titled, "Quality Assessment Performance Improvement Monthly Dashboard. "

6. The Director of Performance Improvement provided the " August Quality Assessment Performance Improvement Monthly Dashboard FY 2013 " for review. Quality Improvement indicators related to the medical care provided by the medical staff were either at their target or " not applicable " , with four exceptions. These exceptions were: " Aspirin at Arrival, Target 100%, Result Jun-13 - 50%, Comment, 2 Cases (1 Failed) Preprints Not Used " , " Prophylactic IV Antibiotic initiated within one hour prior to Surgical Incision, Target,100%, Result Jun-13 - 0%, Comment, 1 case: antibiotic not ordered/given " , " Median Time to ECG < 10 minutes, Target 100%, Result, 67%, Comment, 3 Cases (13 min, 1 failed) " , " Head CT scan results for acute ischemic or hemorrhagic stroke patients who received scan interpretation within 45 minutes of ED arrival, Target 100%, 50%, 2 cases (74 minutes, 1 failed) " . There was no evidence that the medical staff did any work to improve these indicators that did not achieve their targets with the exception of the work presented related to Troponin and CT/MRI as described below.

7. During an interview on November 19, 2013, the Manager of Performance Improvement said that with the exception of two projects, Head CT interpretation time and Troponin turn around time, the medical staff was not working on improving any of the performance measures on the dashboard.

8. On November 20, 2013, a meeting was held with representatives of the Medical Executive Committee to discuss Medical Staff Performance Improvement. Five physicians including the Chief Medical Officer were present. The physicians were asked to discuss Medical Staff Performance Improvement initiatives that involved measurable evidence of Performance Improvement.

9. The pediatric member of the Medical Executive Committee described an initiative to update the dose of Vitamin K given to newborns. He said that the dosage recommendations had changed, and the quality initiative was to update the dosage. The pediatrician stated that the policy change represented higher quality care since they were performing consistently with current national guidelines.

10. The minutes of the Perinatal Committee from July 2012 through October 2013 were reviewed. The minutes of the October meeting state, "Vitamin K Administration for Newborns. The Committee agreed to change the dosage from 0.5 mg IM to 1.0 mg which is the current recommendation by the American Academy of Pediatrics. Also, the policy has been changed to allow for Vitamin K to be given within "4 hours of delivery" as this would allow mothers and newborns uninterrupted time for initial breastfeeding and bonding." The minutes do not describe a process improvement initiative to measure the percentage of time that Vitamin K was given, nor was there any evidence that Vitamin K administration rates were below an established threshold, nor was there any evidence of plans to measure the results of this policy change.

11. There were no quality improvement initiatives related to the care of pregnant patients. This was confirmed by the Director of Performance Improvement and by the members of the Executive Committee.

12. During the meeting with the members of the Medical Executive Committee on November 20, 2013, the Emergency Physician representative stated that there are too many requirements from the Federal government, but did not describe any emergency physician performance improvement initiatives.

13. The Operating Room and Outpatient Procedures spreadsheet for 2013 was reviewed. The Surgeons at Waldo County General Hospital perform ENT, Ophthalmologic, Podiatric, Urologic, Gynecologic, Orthopedic and General Surgical cases in 2013. This includes major joint replacement, bowel resections, and other major surgeries confirmed by the Chief of Anesthesia who was interviewed during a meeting on November 20, 2013.

14. The Director of Performance Improvement was asked during meetings on November 20 and November 21, 2013, to provide evidence of quality improvement initiatives for surgery and the surgical specialties, involving quantitative measures of performance and to demonstrate improvement in physician performance. He said that would be found in the minutes of the endoscopy process Improvement Task Force. He provided minutes of the Endoscopy Process Improvement Task force.

15. The minutes of the Endoscopy Process Improvement Task Force were reviewed. The final meeting of this Task Force was August 15, 2010. No measurements related to the improvement of the quality or safety of endoscopic procedures were provided subsequent to 2010.

16. On November 21, 2013, the Director of Performance Improvement said the Surgical Champion of the Endoscopic Task Force would have additional information relevant to surgical quality.

17. During a meeting on November 21, 2013, the Surgical Champion of the Endoscopic Task Force was asked if there were any measurable improvement outcomes that he could produce relating to endoscopies and he said he did not have any data.

18. The Surgical Champion of the Endoscopic Task Force stated that the Chief of Surgery was away on vacation and was not available. He said they are using NSQIP, (National Surgical Quality Improvement Program), from the American College of Surgeons as their quality initiative. He described that they are in the process of entering their data and ensuring that the coding of the data is accurate and " statistically significant " . He said they have not used reports from the NSQIP database to initiate any process improvement initiatives.

19. During the interview on November 21, 2013, the Surgical Champion of the Endoscopic Task Force said he was a "Lean, Six Sigma Black Belt". He was asked if there were any quality improvement initiatives in surgery or the surgical specialties involving a quantitative assessment of performance along with initiatives to improve measurable performance. He answered, " No " .

20. The Chief Medical Officer said that the Waldo County Emergency Department sees 16,800 patients annually. He stated there were two Emergency Physician quality initiatives in 2013. These were " Troponin turn-around time " , and " Head CT or MRI scan results for Acute Ischemic Stroke or Hemorrhagic Stroke Interpretation within 45 minutes of ED arrival". He could not describe that these initiatives involved any change in emergency physician performance.

21. The Director of Performance Improvement provided the Troponin turn-around time " PDSA Cycle Worksheet " for review. This worksheet describes the project as, " Plan ...Laboratory Turnaround times for Troponin should be under one hour."

22. The minutes of the Troponin turn around time project document meetings to decrease laboratory turn around time. There was no evidence in these minutes of any initiatives relating to improving the care of patients by emergency physicians.

23. The second Emergency Department PDSA Cycle Worksheet presented was the Head CT or MRI scan results for Acute Ischemic Stroke or Hemorrhagic Stroke Interpretation within 45 minutes of ED arrival". The only times recorded in this study were the arrival time and time the CT/MRI results were interpreted by the radiologist. No evidence was presented that the care provided by emergency physicians was included in this project.

24. A review of the " Quality Assessment Performance Improvement Peri-Operative Services " Plan for the fourth quarter of 2012 and first through fourth quarters of 2013, failed to contain effective improvement data for selected indicators as exampled by the following:
Indicator = " Patients will have a SPO2 ? 92% upon arrival to PACU "
Goal for 4th QTR FY 2012 and 1st through 4th QTR FY 2013 is " 100% " . None of these reported quarters have achieved the 100% goal.
Both the " Prior Results " and Current Results " column header state: " ... had a SPO2 of 92% or less on arrival to Recovery Room " .
The PACU "Improvement Plan" for " 4th QTR FY 2012 " and " 1st QTR FY 2013 " states: " Numbers will be reported to anesthesia. Continue to monitor "
The PACU "Improvement Plan" for " 2nd QTR FY 2013 " states: " Continue to monitor to ensure there are no marked discrepancies in trends. "
The PACU "Improvement Plan " for " 3nd QTR FY 2013 " and " 4th QTR FY 2013 " states: " Communication of data to providers involved in patient care."

25. The " ACA " Indicator " Patients who respond that their pain was controlled ' always ' in follow up phone call " failed to have a Goal indicated for the fourth quarter of 2012 and first through fourth quarters of 2013, and contained no reported data for first through fourth quarters of 2013.

26. Both indicators for the " Perioperative " Unit failed to contain data for the Fourth Quarter 2013 (July-September 2013).

27. These findings were confirmed by the Perioperative Services Manager on November 20, 2013, at approximately 2:00 p.m.

28. Review of the Medical/Surgical program for Quality Assurance and Performance Improvement (QAPI) indicated that there was no data collected since April 2013.

29. The above finding was confirmed by the Medical/Surgical Nurse Manager, on November 21, 2013, at 10:20 a.m., who stated, "we haven't been monitoring quality since the April 2013 review".

30. Review of the QAPI plans for the Outpatient Clinics indicted that for each of the clinics with an indicator, after review of results, each "improvement plan", indicated, "to continue with monitoring".

31. The Pulmonology Clinic had two indicators, with a goal of 90% for each. When the indicators did not achieve their target, the plan was to "review records to verify Spiro done within 12 months", each quarter."

32. The Foot & Ankle Clinic had two indicators, one clinical and one safety. When the clinical indicator achieved its goal for three consecutive quarters, there was no evidence that a new clinical indicators were developed. The Safety indicator was " all patients who are provided patient education handouts will have it documented in the office notes". When the clinic failed to achieve sustainable improvement in any quarter, there was no evidence of actions taken to achieve improvement.

33. Gynecological and Obstetrical Services had two indicators, 1. Percentage of pregnant patients who received cystic fibrosis counseling, and documentation of number of interested patients who take cystic fibrosis test kit, and 2. Percentage of patients receiving pre-op counseling explaining risks and benefits of surgery in the office. The first and second indicators had a goal of 100%. Despite the lack of improvement over 4 quarters, the plan was "continue to document in chart".

34. The Cardiovascular Services had five indicators and the improvement plan for all five was continue to monitor for all four quarters.

35. Surgical Services had two indicators and the improvement plans for all four quarters were "to continue with monitoring" for one and "collecting data for next reporting period" for the other, if they reached their goal or not during each quarter.

36. Diabetes Services had two indicators and they were, review for a lipid profile, and review for annual eye exam. For both indicators during all three quarters (for those that did not have an update), the plan was "these charts have been flagged to check for the lipid panel at the next clinic." There was no indication of if they did the next quarter. There were no goals set for either indicator.

37. The Searsport Health Center had two indicators, with an improvement plan for the first of "continue to monitor" and the second indicator was changed in the third reporting quarter with no documentation to explain the change.

38. The above findings were confirmed by the Physician Services Manager on November 21, 2013, at approximately 2:30 p.m.

39. While Obstetrics, Surgery, Emergency Medicine, Medical/Surgical Inpatients and Outpatient Clinic patients represent high risk and high volume practices at Waldo County General Hospital, the hospital failed to document meaningful performance improvement initiatives in these key areas of patient care.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes and evaluate all patient care services and other services affecting patient health and safety.


Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding the evaluation of the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes or the evaluation of all patient care services and other services affecting patient health and safety.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.

Based on review of the Waldo County General Hospital Annual Program Review Critical Access Hospital 2013, on November 20, 2013, it was determined that the facility failed to consider the findings of the evaluation, including any findings or recommendations of the QIO, and take corrective action if necessary.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding the findings of the evaluations, including any findings or recommendations of the QIO, and/or any corrective actions if necessary.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.

3. Please see Tag C-0336 for additional information regarding the quality assurance program.

Based on review of the Waldo County General Hospital 2013 Annual Program Review Critical Assess Hospital FY 2013, on November 20, 2013, it was determined that the facility failed to take appropriate remedial action to address all deficiencies found through the quality assurance program.

Findings include:

1. The annual program review document, reviewed in its entirety on November 20, 2013, did not include any documentation regarding taking appropriate remedial action to address all deficiencies found through the quality assurance program.

2. During an interview with the Director of Quality on November 20, 2013 at approximately 3:30 PM, he stated that there was no other additional information/documentation regarding the the annual program review in addition to what the surveyor had already reviewed.