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Based on a tour and observations of the Second Street Family Practice and interview with key personnel on January 11, 2012, it was determined that the drugs that are stored in the storage area was not administered in accordance with accepted professional principles.

The findings include:

1. The Second Street Family Practice (SSFP) drug sample receipt and dispensing log,(an Excel spreadsheet), indicated that there were medications in inventory with no amount of pills listed and some dispensed medications listed which had no number of pills dispensed.

2. In addition, review of the medications log for the drug Zyprexa 10 mg, indicated under the "inventory"column, the received section, that there were two hundred fifty-two (252) pills received. However, a total of one hundred twenty six (126) pills had been dispensed, but the bin count continued to reflected two hundred fifty two (252) pills on their drug sample receipt and dispensing log.

3. The Director of Outpatient Services stated that they didn't have the correct formula on the Excel spreadsheet.

4. The Second Street Family Practice(SSFP) inventory sheet was corrected for the Zyprexa 10 mg (milligram) to reflect a correct total in the bin of one hundred twenty six (126) pills.

5. In an interview with the Director of Outpatient Services on January 13, 2012, he stated that they had counted all the medications in the bins and established a new inventory. He also stated that they were accurate for about 20% only.

Based on observation of the Second Street Family Practice(SSFP), review of Saint Mary's Health System policy "Drug Sample" and interview with key personnel on January 11, 2012, it was determined that the hospital failed to assure medications were dispensed in accordance with accepted professional principles.


The findings include:

1. St. Mary's Health System administrative policy, "Drug Samples", directed staff, "all samples provided to a patient must be documented in the patient's medical record. Samples supplied to patients must be labeled with the following information: Patient name, dispense date, prescriber name, quantity dispensed and instructions for patient administration."

2. MRSA Title 32, Chapter 117: Maine Pharmacy Act, 32 ? 13731. Unlawful Practice: Penalties; Injunctions 1. Applicability states, "It is unlawful for any person to engage in the practice of pharmacy unless licensed to practice under this Act, provided that physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed under the laws of the State may dispense and administer prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by law."

3. An interview conducted with the Medical Assistant (MA) and the Practice Manager at the SSFP, indicated the distribution of sample medications to patients was as follows: The physician orders the medications from the sample closet, the MA bags the medication, and types out a paper with the physician's name, the medication, dose, patient name, directions, and the lot number with expiration date. This is stapled to a bag and placed out in front in a locked drawer and the clerk in the front office gives the medication to the patient after he/she signs for it. These medications are not reviewed by the physician prior to dispensing to patients.

4. This finding was confirmed by the Practice Manager on January 11, 2012.

Based on tour of the Second Street Family Practice (SSFP), observations and interview with key personnel on January 11, 2012, it was determined that the facility failed to assure outdated drugs and biological's were not available for patient use.

Findings include:

1. St. Mary's Regional Medical Center Pharmacy Department Policy, "Medication Expiration Dates", specifies the following for Multi-dose vials, "all multi-dose vials shall have an expiration date of 28 days after opening."

2. During a Second Street Family Practice tour of the laboratory room, the following outdated medications were found:
Five ( 5) boxes of sterile dilutant, each box with 10 -0.7 ml (milliliters) vials, with a manufacturers expiration dates of: 5/11, 8/11, 9/11, 11/11 and 9/11.
A vial of sterile water, 20 ml opened with no open date.
Two (2) vials of Lidocaine, 1 -1% opened on 10/25/11 with an expiration date of 11/25/11, and the other, 2% opened on 11/21/11 with no expiration date written on the vial.
An ampule of Omnipaque 240 with an expiration date of 7/22/11.
3. In the refrigerator of the laboratory room, the following outdated medications were found:
An open vial of Influenza vaccine, with a written expiration dated of 11/10/11, and a second opened influenza vaccine vial with no expiration date.
Seven (7) vial of Hepatitis B vaccine with a manufacturers expiration date of 11/24/11.
An open vial of Poliovirus vaccine with an expiration date of 12/1/11.
An open vial of Tetanus Toxoid with an expiration date of 12/17/11,
Two (2) vials of Tuberculin PPD (purified protein derivative) both open and no expiration date on them.

4. In the orthopaedic storage room, there was a 30 ml (milliliter) vial of Nesacaine which had a written opened date of 12/13/10.

5. These findings were confirmed by the Director of Outpatient Services on January 11, 2012.

Based on a tour of the hospital environment and interview with key staff on January 10, 11, 12 and 13, 2012, it was determined that the condition of the physical plant and the overall hospital environment was not developed and maintained in such a manner that the safety and well-being of patients are assured.

The findings include:

A tour of the Adult Psychiatric Unit and the Radiology Department was conducted on January 10, 2012 and the following findings were found:

1. Rooms A 328, A 329, A 349 , A 343, A 34, B 307 had walls with gouged out areas or peeling paint .

2. The Nurse's Station on the Adult Psychiatric Wing had gauged out door frames, torn Formica desk areas, worn varnished cabinets and wood trim, soiled chair pedestals. The "Back Room" of the Nursing Station had a large rust area on the floor, adjacent to an old steel cabinet. The flooring was soiled and the wall paint was worn.

3. The Kitchen area on the Adult Psychiatric area had gouged door frames and areas along the radiator with no paint, exposing the sheet rock.

4. The main hallway on the Adult Psychiatric Unit had gouged out wall areas.

5. The shower room A 336 had peeling paint and the shower room A 348 had a very rusted shower rod holder with the shower wall needing repair.

6. On the Adult Psychiatric Unit, Room A 349, there was an area of wall paper repaired with clear tape.

7. The Plastic wall edging on the door frames was either gone or torn from rooms A 353 and A 349.

8. The staff lounge on the Adult Psychiatric Unit had remnants of an old curtain rod hanging from the wall and gouged walls.

9. On the Adult Psychiatric Unit, room A 324, had two window locks that were shaped in such a manner as to be a potential safety issue for psychiatric patients.

10. On the Adult Psychiatric Unit, Room A 339, Bed A, had a rusted dusty bed frame.

11. The hallway housekeeping closet on the B 3 Wing area had soiled, gouged walls and the floor drain was very worn.

12. On the Adult Psychiatric Unit Behavioral Intensive Care area, the Nursing Station had a large stained area adjacent to the wall hand sanitizer dispenser.

A tour of the Cardiac Cath Lab in the Radiology Department was conducted on January 10, 2012 and the following findings were found:

1. The door in Angio suite C-140 was deeply gouged and not easily cleaned and sanitized.

2. The floor in Angio suite C-140 was soiled and the corners had built up soil present.

3. The Cardiac Stress Testing tilt table cover was torn and not easily sanitized. There was also a positioning wedge on the table that was torn.

A tour of the Nuclear Medicine Department was conducted on January 10, 2012 and following finding was found:

1. The walls in the Nuclear Medicine Department had chipped and gouged walls.

A tour of the operating room was conducted on January 11, 2012 and the following findings were found:

1. Minor Room 1: the casters on the ring stand, IV pole and the casters of a table were rusty and unable to be sanitized.

2. Minor Room 2: the casters on the ring stand were rusty and unable to be sanitized.

3. OR 2,3, the casters on the ring stand and 2 tables were rusty and unable to be sanitized.

4. OR 4: the casters on one table were rusty and unable to be sanitized.

5. OR 6: the casters on the ring stand and 1 table were rusty and unable to be sanitized.

6. This was confirmed by the Nurse Manager of the OR on January 11, 2012.

A tour of the Children's Psychiatric Unit was conducted on 1/10/12 and the following findings were found:

1. Door trims were damaged with paint chipped for Rooms 226, 228, 235, and 240.

2. Three ceiling tiles were stained in Room 240. One ceiling tile was cracked.

3. Hallway paint was damaged near Room 228 and 237.

4. A rug on the wall was stained near Room B 207.

5. The wall in B-213 was patched, but not painted. Paint was chipped in Room A 226.

6. In Room B-217, the wall was stained in the bathroom and the floor behind the toilet was dirty. The bottom of the sink cabinet was damaged making the surface unable to be sanitized.

7. Mop boards were missing in front of the seclusion room.

8 Window trim paint was damaged in the Dining Room.

9. The bedside stand was worn in Room B 211.

A tour of the main hospital building,which included the lower levels and the ICU on 1/12 and 1/13/2012. The following was found:

1. Central storage room B-109, the flooring under the movable shelving units, lacked a washable surface.

2. In the ICU, a cabinet under the sink in the break/meeting room, contained paper reports stored loosely in a plastic bin.

3. The microwave in the ICU E 289 had rusted surface on the interior both to the top and by the contact surface of the door. These areas are no longer easily cleanable or able to be sanitized.

4. The wooden edge of the lavatory was damaged in Room 9.

In a tour of the Dietary Department on 1/13/12 with Dietary managers the following was found:

1. The floor in the food storage room was badly cracked and tiles were missing.

2. The counters in the galley were worn and no longer able to be easily sanitized. The blue color surface of the counter was worn off in the cold set up area and near the sink.

3. The dishwasher in the galley was leaking out on the floor.

In a tour of the Great Falls Orthopaedic Practice on 1/11/12 the following was found:

The wall in Room 5 was water damaged directly under the window and also down near the floor.







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Based on review of meeting minutes, review of performance improvement reports, and other documents as described below, along with interviews with key staff on January 10, 11, and 13, 2012, it was determined that St. Mary's Regional Medical Center (SMRMC) failed to engage in performance improvement activities as described in the Hospital ' s Quality Plan, and failed to put into place processes to ensure that all patients receive an appropriate medical screening exam.

Findings include:

1. The St. Mary ' s Regional Medical Center Quality Plan Section A, " Strategy " stated, " SMRMC has adopted FOCUS-PDSA, [Find, Organize, Clarify, Understand, Select, - Plan, Do, Study, Act], as its primary methodology to investigate, assess, and act upon opportunities to improve performance and patient safety. "

2. According to the Chief Medical Officer and the Director of Performance Improvement during meetings on January 10, 11 and 13, the document titled " 2011 QI Indicators " contained the results of physician quality improvement activities for 2011.

3. The Director of Performance Improvement said at the time of the survey, and confirmed in an e-mail message dated January 13, 2012, the emergency physicians ' performance improvement initiatives for 2011 were: " Door to Provider: 90% seen within 30 minutes " , " Patient Satisfaction with Pain Management, 85 th percentile of national vendor (Picker) " : " Patient Satisfaction with Physician Care 90 th percentile " ; " Hand Hygiene: organization-wide initiative and interventions Goal 90%" ; and " Pneumonia: Blood Culture before Antibiotic Goal: 100% " .

4. The emergency physician indicator results were reviewed. Only the "Pneumonia; Blood Culture before Antibiotic " showed sustained improvement. The remainder of the indicator results did not show sustained improvement and were as follows:

a. The " Door to Provider Time within 30 minutes " listed a goal of 90%. The results for the months January through October, listed monthly were, 66%, 60%, 59%, 61%, 60%, 57%, 70%, 69%, and 69%.

b. The goal for " Pain Management " was 85%. There were three results, in February, 45.9%; May, 46.8%; and August, 31.6%.

c. The indicator reference by the Director of Performance Improvement as Patient Satisfaction with Physician Care in the 2011 QI Indicator spreadsheet was labeled, "Physician Care: Confidence and Trust in Nursing Care, Target 90 th % ". Results were, February, 68.1; May, 78.5; August, 68.5.

d. The indicator labeled, " Provider Hand Washing " , listed a target of 95%. Monthly results from January through October were, 88%, 80%, 20%, 60%, 87%, 80%, 100%, 100%, 60%, and 50%. The Director of Performance Improvement in an e-mail message on January 13, 2012 described these results, as " Significant variability from 20% to 100%. " There was no consistent, or sustained improvement in performance for the indicators: Door to Provider: % seen within 30 minutes, Patient Satisfaction with Pain Management, Patient Satisfaction with Physician Care or Hand Hygiene.

5. The 2011 Emergency Physicians meeting minutes were reviewed. These minutes did not contain evidence that the emergency physicians took steps in order to improve their performance on their quality indicators of hand hygiene, patient satisfaction with pain relief, patient confidence with physician care, or time to provider within 30 minutes. These minutes did not contain evidence of FOCUS-PDSA, [Find, Organize, Clarify, Understand, Select, - Plan, Do, Study, Act], " as described in the Quality Plan.

6. Interviews were held with the Director of Performance Improvement on January 10, 11, and 13, 2012, and the Director of Performance Improvement and the Chief Medical Officer on January 11 and 13, 2012 regarding the quality improvement activities of the emergency physicians. Both the Chief Medical Officer and the Director of Performance Improvement confirmed that the emergency physicians had not demonstrated sustained improvement, nor achieved the goals of " time to provider within 30 minutes " , " satisfaction with pain management " , " patient satisfaction with provider " , or " hand hygiene " . They further confirmed that the emergency physicians were not involved in additional performance improvement activities, teams or meetings, or other evidence of " FOCUS-PDSA " in order to achieve these performance targets.

7. In September 2011, as a result of a complaint investigation, St. Mary ' s Regional Medical Center was found to be out of compliance with the Condition of Participation " Emergency Services " , (?482.55). " St. Mary's Regional Medical Center (SMRMC) failed to complete an accurate, appropriate medical screening examination, even after the patient was under the care of several emergency physicians, which resulted in not identifying the patient's emergency medical condition and not providing stabilizing treatment for the patient's condition " . (See Form CMS-2567 (Statement of Deficiencies) dated 9/26/2011).

8. During the survey, on January 10, 2012, a meeting was held with the Chief of Emergency Medicine and the Interim Director of Emergency Services. They were asked what measures had been taken to resolve the issues documented in the September 26, 2011 Statement of Deficiencies. The Chief of Emergency Medicine said he had seen the September 2011 Statement of Deficiencies, and held a staff meeting with the emergency physicians to discuss the case and educate them about EMTALA, but he had not taken any other actions. He said he had not developed any new policies, procedures, or new processes. He said he could not think of any way that the on-coming emergency physicians could ensure that incomplete items were addressed prior to discharge or transfer. He confirmed that he had not developed a checklist for physicians to use for this purpose.

9. During this meeting, the Interim Director of Emergency Services said he had done a chart review to determine if documentation had been complete, but he had no record of the charts reviewed, or the specific results of that review.

10. The hospital undertook a root cause analysis, according to the Director of Performance Improvement, which was completed in October 2011 and included the Chief of Emergency Medicine. The action steps were presented to the survey team in a meeting on January 11, 2012 attended by the Director of Performance Improvement, the Chief Medical Officer, the Chief of Emergency Medicine, the Chief Nursing Officer and the Interim Director of Emergency Services. After the meeting, a copy of the " Action Plan " from the root cause analysis was provided to the survey team.

11. In the " Action Plan " Item 1 stated, " Action, Develop and implement documentation process in Meditech to allow documentation when exam or assessment is restricted " . The " Measure of Effectiveness; Audit records to determine presence of documentation " . The " Responsible Person " was the Chief of Emergency Medicine, and the, " Target Date, 2/2012 " . There was a " Comment; Work on manual process first to prevent implementation delay " .

12. Item 3, " Action, " Hand off: Develop hand off checklist for verbal shift to shift hand off of ED patients " , had a Measure of Effectiveness of, "Audit records or perform observation depending upon checklist mechanism " , the responsible person was the Chief of Emergency Medicine, the target date was, " 1/2012 " .

13. On January 10, 2012, the Chief Medical Officer was asked if measures had been taken to correct the problems found during the September complaint investigation and documented in the Statement of Deficiencies. He said that the emergency physicians had received EMTALA training. He said he was not aware of any other work and that no checklist for ensuring completion of pending tasks had been developed. He confirmed that there had been no work done to ensure that patients receive an appropriate medical screening exam prior to discharge or transfer.


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