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Based on observation, interview and document review, the Hospital failed to have an effective Governing Body that was responsible for the conduct of the hospital related to adequate patient safety with medication administration, verification and storage of patient's medications brought from home. The Pharmaceutical Services were not coordinated in a manner to ensure the safety of patients and utilize data to minimize medication errors. In addition, the Hospital failed to ensure that staff followed Hospital policy for not accepting verbal orders. Finding include:

According to the Hospital's Governing Body Bylaws dated 12/2013, on page 1, it stated the following: "the purposes for which the corporation is formed are to equip, maintain, and staff a health care system which would provide the most effective treatment, intervention, prevention, and educational services in the specialty field of addictive diseases with particular emphasis on substance abuse." On page 6, it stated: "working continually with other health care professionals to the end that high quality care may be rendered to the patients at all times."

1. Adequate patient safety practices were not followed for medication administration, verification and storage for medications which the patients brought from their homes to prevent medications errors.

a. Observation during a medication pass on 9/2/14 at 9:20 A.M. and at 9:25 A.M., indicated medications the patients brought from their homes lacked safe practices to prevent medications errors. Strips of preprinted medication labels were stored on top of multiple prescription bottles from the patient's community pharmacies. During the medication pass, these strips of labels, which were not affixed to the medication bottles, were entered into the electronic medication administration record by a scanning device. This process bypassed the safety feature of having fixed labels, containing the bar code that identified the name of patients' medications, affixed to the specific prescription medication containers.

b. Review of the Nursing and Pharmacy policies indicated the facility did not have policies for medication administration, verification or storage of medications related to prescription medications that were brought from the patients' home. The manufactures guidelines for the electronic medication verification system was not followed. During the medication passes the verification process for preventing medication errors was bypassed.

c. During an interview on 9/3/14 at 1:10 P.M., the Director of Nurses said that the Hospital did not have written policies or procedures for administration, verification, or storage of patients' personal, prescribed medications that the patients brought from home.

Please refer to A490 and A500.

2. Review of the Executive Committee of the Medical Staff minutes of 9/4/14, indicated that Nurses accepting verbal orders from the Physicians in nonemergent situations was not an acceptable practice and continued to be a problem for the Hospital.

a. For Patient #27, the Hospital staff failed to adhere to the Hospital's policy for not accepting or writing verbal orders except in emergency situations. Based on review of Hospital's policies and interview with Nurse Manager (NM) #3 on 9/2/14 at 2:50 P.M. and interview with the Director of Nurses on 9/3/14 at 1:10 P.M., the hospital staff are not allowed to take verbal orders. During an interview, on 9/2/14 at 12:10 P.M., NM #3 stated that she accepted a verbal order for Patient #27 for Coumadin (blood thinning medication) during rounds that morning.

b. The Hospital failed to follow the State Board of Registration in Nursing Regulations [244 CMR 9.03(38)], related to Administration of Drugs, "A nurse licensed by the Board shall not administer any prescription drug or non-prescription drug to any person in the course of nursing practice except as directed by an authorized practioner."

c. Review of the Executive Committee of the Medical Staff Minutes of 11/25/13 indicated a Nurse Practitioner gave a verbal order to the Charge Nurse for the medication Phenobarbital (prevents seizures). The Charge Nurse then passed the verbal order along to another nurse, who administered the Phenobarbital to the wrong patient.

Please refer to A407.

3. The Hospital failed to ensure staff administered a proton pump inhibitor (PPI) medication for gastroesphageal reflux disorder (GERD) at the appropriate time in relation to meals. Observation during a medication pass on 9/2/14 at 9:20 A.M., for Patient #6, with diagnoses of GERD and gastric bypass surgery, was given the PPI 50 minutes after starting breakfast.

a. Review of the medication manufacturer's directions for use (MDFU) indicated that the PPI medication was to be administered one hour before meals. The PPI blister pack was not labeled to be administered one hour before meals per MDFU, nor was there a note on the medication administration record (MAR) to that effect.

b. Review of the Quality Environment/Safety Committee minutes on 9/3/14, indicated there were medication errors with the bar codes (related to "bad scans") for medications. This system had been implemented in 2012 with the electronic medical record.

Please refer to A405.

4. The Hospital failed to ensure that a supervising Pharmacist provided comprehensive, coordinated Pharmaceutical Services that ensured the safety of current patients and utilized data to proactively minimize medication errors for future patients.
A review of Nursing medication use policies did not reflect Pharmacy involvement in the development of these policies. Nursing assumed responsibilities (e.g., verification of patients own medication with retail pharmacies) that are the responsibility of a pharmacist as follows:
a. The High Risk Medication Policy did not identify Hospital practices designed to minimize risk.
b. Pharmacy policies did not address drug-utilization and formulary initiatives that optimized therapeutic outcomes, and reduced the risk of drug-related problems.
c. Review of Pharmacy documentation indicated that the Hospital lacked proactive oversight by a pharmacist to monitor, track and trend the use of controlled substances for effectiveness and to prevent diversion and/or tampering.
d. Review of Pharmacy performance improvement, indicated that the quarterly review of medication errors lacked drug names that would allow trending and tracking the effect of error minimization strategies.

Please refer to A492.

Based on observation, record review and interview the Hospital failed to provide personal privacy for 1 Patient (#5) from total sample of 30 Active Inpatients. Findings include:

According to the Hospital's Statement of Patient's Rights, it states, "AS A PATIENT YOU HAVE THE RIGHT: To confidentiality of all medical information about your case. To have your privacy respected at all times during care or treatment."

Patient #5 was admitted to the Hospital on 9/1/2014 for opiate and alcohol dependency.

Observation by Surveyor #1 on 9/2/14 at 10:00 A.M. on Unit 4 East, found Registered Nurse (RN) #4 examining Patient #5 (who was seated in a chair in the hallway). RN #4 asked this Patient to extend his/her hands and arms in front of him/herself to check for tremors and then touched the back of this patients neck and upper back. The Patient said, "I am having a headache." This nurse proceed to obtain a headache history in the hallway. There were 3 other Patients and multiple staff in the hallway at this time, who observed RN #4 interacting with Patient #5 and could hear the conversation between RN #4 and Patient #5.

During an interview on 9/2/14 at 10:05 A.M., Surveyor #1 asked RN #4, "What were you doing with Patient #5 in the hallway?" She said, "I was checking for tremors with the arms. You go behind the neck and check for sweats."

Based on record review, policy and procedure review and interviews, the Hospital failed to ensure care in a safe setting for 2 Patients (#20, #26) from a total sample of 30 Active Inpatients.

Findings include:

1. For Inpatients #20 and #26, observations on the 2 West Unit, on 9/2/14 at 9:40 A.M., indicated that the Patients' bathroom doors had a slide lock on the bedroom side (the outside), as well as a lock on door handle on the inside of the bathroom doors. The lock on the door handle could be released by staff in the event of an emergency. However, the slide lock did not have a quick-release mechanism and could not be released by staff, creating a risk for patient safety. During interview at the time of the observation, Licensed Practical Nurse (LPN) #2 said that all Hospital patients' rooms had slide locks on the bedroom sides of the bathroom doors.

This practice created a risk for patients to lock the bathroom door, with the slide locks, from the side of their bedrooms and then barricade the door of the main entrance into their rooms, with the intension of harming themselves, thereby delaying entrance and intervention by staff. Staff would not have immediate access to the patients in the event of an emergency. Both Patient #20 and Patient #26 had diagnoses that included depression and anxiety.

During interview on 9/2/14 at 10:00 A.M., the Nurse Director of the 2 West Unit said that when the Hospital applied the locks to the bathroom doors, it was with the intent to keep patients from adjoining rooms from unauthorized entrance to a patient's room, without being noticed by staff. The Nurse Director said that the risk for patients to be able to barricade themselves in a room and hinder immediate staff entrance in an emergency situation was not considered.

Based on document review and staff interview, the Hospital failed to adhere to Medical Staff Bylaws and re-appoint members to the Medical Staff every 2 years, for one Physician (#8) out of 13 physician files reviewed. Findings include:

Review of the Medical Staff Bylaws, dated July 2014, under the section labeled "Condition and Duration of Appointment," indicated, "Reappointment to the Medical Staff shall be for a two-year period to coincide with the reappointment process."

1. Surveyor #1 reviewed the credential file of Physician #8 (a Fellow) who was last reappointed to the Medical Staff in 12/2009. Physician #8 was only priviledged to perform patients' histories and physicals. This file did not contain evidence of reappointment every 2 years, as required by the Medical Staff Bylaws.

2. During Surveyor #1's interview with the Medical Director on 9/4/14 at 11:30 A.M., he said that he did not think he needed to reappoint a Physician every 2 years, who only had limited privileges to perform just histories and physicals.

Based on record review and staff interview, the Hospital failed to develop, keep current, and include all patient current care needs in nursing care plans for 7 Patients (#9, #10, #12, #24, #25, #26 and #27) from a total sample of 30 Active Inpatients.

Findings include:

According to the current Hospital policy titled "Nursing Documentation" indicated that a nursing assessment was to be initiated at the time of admission, completed as soon as possible, but no more than 24 hours by a licensed nurse. The nurse then developed and updated a treatment plan (care plan), based on the assessment.

Additionally, the Hospital policy titled "Role of Nursing in Patient Admission" indicated that a nurse completed a nursing assessment and created a problem list based on the assessment. Based on the nursing assessment and current problem list, care interventions that included the physiological, psychological, and emotional condition of a patient would then be developed and implemented.

1. For Patient #24, admitted with diagnoses that included chronic pain and seizures, the Hospital failed to ensure that the patient's plan of care included goals and interventions for seizures and pain. Review of the nursing admission assessment indicated that the Patient reported a seizure had occurred prior to admission.

During interview on 9/2/14 at 2:30 P.M., Licensed Practical Nurse (LPN) #2, said the care plan should have included goals and interventions for pain and seizures.

2. Patient #25 was admitted with a diagnosis that included schizoaffective disorder with a history of suicide attempts, hallucinations and delusion, and a diagnosis of sleep apnea. The Hospital failed to ensure that the Patient's plan of care included goals and interventions for sleep apnea and the documented psychiatric problems.

During interview on 9/3/14 at 9:45 A.M., Registered Nurse (RN) #7 said the care plan should have included goals and interventions for the above identified problems.

3. Patient #26 was admitted with diagnoses that included chronic back pain, anxiety, depression, and history of falls. A falls assessment was completed and Patient #26 had a fall score of 10 and sustained a fall on 8/13/14.

During interview on 9/2/14 at 2:00 P.M., the 2 West Unit Nurse Manager said that a fall score of 10 determined that a patient was a risk for falls and should have a falls care plan.

Review of Patient #26's care plan indicated that the care plan lacked goals and interventions for pain, falls, anxiety, and depression.


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4. For Patient #9, the facility failed to develop a plan of care addressing a toe infection despite the patient needing topical and oral anti-infective medications applied to the right toe.

Patient #9 was admitted to the facility on 8/31/14, and developed a wound on the right toe (according to the Unit Manager) caused by the patient's sandals rubbing and causing friction/pressure on the area.

On 9/2/14 the Physician ordered the anti-infective ointment Bacitracin to the right toe three times daily as well as the oral anti-infective medication Bactrim, twice daily.

During interview on 9/2/14 at 1:30 P.M., Nurse Manager #3 said that as part of the care plan (which had not been developed yet), staff would monitor the area every time the ointment was applied and document their findings (signs of infection, improvement, decline, odor, redness, etc.).

After review of the clinical record, Surveyor #4 discussed the findings with Nurse Manager (NM) #3 on 9/4/14 at 1:30 P.M. The Surveyor asked NM #3 if she could guide the surveyor to where the care plan for the right toe infection was and where the Surveyor could find the documentation that the right toe was being monitored for infection as stated on 9/2/14. NM #3 searched the electronic record, but was unable to find any evidence of a care plan or nursing documentation that the right toe was being monitored each time the Bacitracin was applied. NM #3 said that a care plan with goals, interventions and timelines should have been developed, but was not done.

Please refer to A450.

5. For Patient #10, the hospital failed to develop a plan of care addressing the blood disorder Hemochromatosis. (This disorder causes a very high iron content in the blood and if untreated may lead to serious heart disease, liver disease, diabetes mellitus and kidney disease.) Treatment sometimes includes blood draws to relieve the high iron content in the blood and limiting iron rich foods in the diet.

Review of Patient #10's admission laboratory data indicated the BUN (blood urea nitrogen) level was high at 24 (normal is 7-23). The GFR (Glomerular Filtration Rate) was moderately low at 55 (normal is greater than 60) If low could be an indicator of kidney disease.

During interview on 9/4/14 at 1:00 P.M., NM #3 said there should have been a care plan developed addressing Patient #10's diagnosis of Hemochromatosis with goals, interventions and timelines, but said that a care plan was not done.

6. For Patient #12, the hospital failed to develop a care plan addressing the Patient's high risk for falls despite the patient having a recent fall as well as a history of falls.

Patient #12 was admitted to the hospital on 8/28/14 with diagnoses including falls, pain, depression, chronic obstructive pulmonary disease (COPD), and alcohol abuse.

Review of the 8/29/14 Fall Assessment indicated Patient #12 was at risk for falls on admission. The Assessment indicated there was a history of falls in the past three months due to "Balance Problems while standing." The Patient also utilized a cane for ambulation, but was independent.

Review of the clinical record indicated that on 9/3/14 at 12:15 P.M., Patient #12 was observed by staff stumbling in the hallway with shortness of breath and having difficulty breathing. The Patient was caught prior to falling and placed in a chair. Patient #12 was sent to the hospital for an evaluation and admitted with an exacerbation of COPD.

During interview on 9/4/14 at 1:45 P.M., the NM #3 said there should have been a care plan developed to address Patient #12's falls and continued high risk for falls with goals and interventions and was not developed.



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7. For Patient #27, the Hospital did not develop a care plan for the current problem of heart valve replacement and treatment with anticoagulant medication.

Patient #27 was admitted 8/29/14 with opiate dependency, history of bilateral heart valve replacements and a cerebro-vascular accident.

Review of Patient #27's medical record indicated there was no care plan for heart valve replacement, its long term treatment with anticoagulant medication and complications.

During an interview on 9/2/14 at 1:30 P.M., with Surveyor #1, Registered Nurse #4 said that a care plan was not developed for (his/her) heart valve replacement and treatment with anticoagulants.

Based on observation, interview, document review and record review, the Hospital failed to adhere to State Regulation and medication administration standards of practice for 1 Patient (#6) from a sample of 30 Active Inpatients and 1 of 2 Nonsampled Patients (NS #1). Findings include:

1. According to Nursing 2014 Drug Handbook, page 1025, it stated, "Prilosec (a medication for Gastroesophageal Reflux Disease (GERD) (under administration) Give drug at least 1 hour before meals."

Patient #6 was admitted 9/1/14 with the pertinent diagnoses of GERD and a history of gastric bypass surgery.

During a medication pass on 9/2/14 at 9:20 A.M. with Surveyor #1, Licensed Practical Nurse (LPN) #1 administered Prilosec 20 milligrams to this Patient (50 minutes after a meal).

During an interview on 9/2/14 at 9:45 A.M., this Patient stated, "I started eating breakfast at 8:30 A.M." When the Surveyor asked, "How are you feeling now?" The Patient said, "I am nauseous."

During an interview on 9/2/14 at 10:00 A.M. with LPN #1, she said that she was not aware that Prilosec needed to be administered before a meal but that we can give it to the patient earlier.



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2. According to the Massachusetts State Board of Registration in Nursing (BORN) Regulations [244 CMR 9.03(38)], Administration of Drugs, "A nurse licensed by the Board shall not administer any prescription drug or non-prescription drug to any person in the course of nursing practice except as directed by an authorized practioner."

For NS #1, review of the 11/25/13 Executive Committee of the Medical Staff minutes indicated that during patient rounds (at this time each patient's medications are reviewed), the Charge Nurse passed a verbal order from a Nurse Practitioner to another nurse, who then gave a medication to the wrong Patient (NS #1).

Both the Charge Nurse, who took a verbal order from the Nurse Practitioner and the nurse who took the order from the Charge Nurse (an unauthorized person) and gave the medication, did not adhere to State BORN Regulations.

Please refer to A407.

Based on medical record review, policy/procedure review, review of Executive Committee of the Medical Staff Minutes, and interviews, the Hospital failed to ensure that staff adhered to Hospital policy regarding verbal orders for 2 Nonsampled Patients (NS #1 and NS #2), and 1 Inpatient (#27), from a sample of 30 Active Inpatients. Findings include:

1. The Hospital Policy titled, Medication Administration, last reviewed 1/2013, stated, "No verbal orders will be accepted."

Patient #27 was admitted originally 8/29/14 with Opiate dependency, a history of bilateral heart valve replacements, and a cerebro-vascular accident.

During a medication pass on 9/2/14 at 11:30 A.M. on Unit 3 East with Surveyor #1, LPN #4 passed a one time dose of Coumadin (an anticoagulant medication) 20 milligrams (mg) to Patient #27.

During an interview on 9/2/14 at 12:10 P.M. with Surveyor #1, Nurse Manager (NM) #3 said, "I was on rounds with the Doctor this morning and that was the dose he wanted." The Surveyor asked, "Did the physician write it?" NM #3 said, "No, he gave me a verbal order."

Review of the electronic physician orders indicated on 9/2/14 at 11:34 A.M. there was an order to give Coumadin 20 mg a one time dose as a telephone order.

Review of the electronic physician orders indicated the physician electronically signed a progress note on 9/2/14 at 12:08 P.M. This progress note stated, "Mechanical Heart Valve Present Rheumatic Disease of Heart Valve/ AVR (aortic valve replacement) and MVR (mitral valve replacement). On coumadin, dose adjusted to home dose 15/20 mg..."

Also, during an interview on 9/2/14 at 2:50 P.M. with Surveyor #4, Nurse Manager #3 she said, "That there are no verbal orders in this facility."

During an interview on 9/3/14 at 1:10 P.M. with Surveyor #1, the Director of Nurses said, "We do not take verbal orders. We do not let them do that."

During an interview on 9/4/14 at 8:45 A.M. with Surveyor #1, NM #3 stated that she misspoke, that the coumadin order for Patient #27 was not a verbal order but a telephone order. The Surveyor asked, Is a telephone order a type of verbal order?" She said, "It is." Surveyor #1 asked, "Where was the Physician when this order was given?" NM #3 said, "In his office." The Surveyor asked, "Where is his office?" She stated, "In this building."

During review of the Executive Committee of the Medical Staff minutes on 9/4/14, indicated that Nurses accepting verbal orders from the Physicians in nonemergent situations was not an acceptable practice and continued to be a problem.


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2. For Patient NS #1, the 11/25/13 Executive Committee of the Medical Staff Minutes indicated the following:

A Nurse Practitioner gave a verbal order to the Charge Nurse for the medication Phenobarbital (prevents seizures). The Charge Nurse then passed the verbal order along to another nurse, who administered the Phenobarbital.

As the Nurse Practitioner did not write the Phenobarbital order, which would have indicated the name of the patient intended to receive the medication, the nurse administered it to the wrong patient.

The Executive Committee of the Medical Staff Minutes also indicated that Nurse Practitioners are only allowed to give stat (immediate) verbal orders in an emergency and the order should be immediately entered into the electronic medical record (EMR). This did not occur.

3. For NS #2, review of the 2/24/14 Executive Committee of the Medical Staff Minutes indicated that during patient rounds, a nurse took a verbal order to insert an intravenous (IV) line in Patient NS #2. The nurse inserted the IV based on a verbal order.

The minutes also read that the order for the IV was never written and it was not permissible for nurses to accept verbal orders.

Based on staff and patient interview, observation, Hospital policy and record review, the Hospital failed to ensure that for 1 of 30 Active Inpatient records (#10), nursing staff had documented the following: an assessment of the patient's capacity to self administer a medication; that the patient was instructed on the safe and accurate administration of the medication; address the security of the medication for the patient; and to document the administration of the medication in the patient's Medication Administration Record (MAR), as reported by the Patient. Findings include:

For Patient #10, admitted 8/29/14 with diagnoses including asthma, the Hospital failed to follow their policy and Federal Regulation regarding self administration of medications.

Review of the hospital's Policy and Procedure regarding Medication Administration - Self Administration (reviewed 1/2014) included:
- Each dose of medication shall be properly recorded on the Patient Electronic MAR.

Review of the policy and procedure regarding Patient Education (reviewed 1/2014) indicated: that Nursing Services utilized medication administration as a time for patient medication education regarding medication dose, time, side effects, food drug interaction and expected length of use, if appropriate." The Procedure included the following:
- "Introduce medication with a brief explanation of use and expected effects."
- "Describe side effects."
- "Question patient on information during subsequent medication administration."

Review of the Physician's admission orders indicated Patient #10 had an order to receive the asthma medication Albuterol Sulfate via inhaler, 2 puffs as needed, four times daily.

Review of the Nursing 2014 DRUG HANDBOOK pages 83-85 indicated that patients should be taught to perform oral inhalation correctly using the following instructions:
- Prime before first use and shake the inhaler.
- Clear nasal passages and throat. Breathe out, expelling as much air from lungs as possible.
- Place mouthpiece well into mouth, seal lips around mouthpiece, and inhale deeply as you release a dose from inhaler. Or, hold inhaler about 1 inch from open mouth; inhale while dose is released.
- Hold breath for several seconds, remove mouthpiece, and exhale slowly. If more than 1 inhalation is ordered, tell patient to wait at least 2 minutes before repeating procedure.
- Tell patient to remove canister and wash inhaler with warm, soapy water at least once a week.
- Advise patient not to use more frequently than prescribed and not to increase dose or frequency without consulting physician.
- Adverse reactions include tachycardia (abnormally fast heartbeat), palpitations and hypertension and bronchospasm.

During interview on 9/3/14 at 9:15 A.M., Patient #10 said that he/she has been using an Albuterol Inhaler (asthma medication) for a couple of years, and that the hospital ordered one to keep at the bedside per physician's order. The surveyor observed the inhaler next to Patient #10's bed on the table. Patient #10 told surveyor #4 that he/she used it 2 or 3 times a day, and was never given any education about the medication (instructions, storage, medication information). Patient #10 went on to say that staff did not observe him/her self-administer the medication and that he/she did not have to tell staff if he/she used the inhaler. The patient told the surveyor that if he/she used the inhaler too often, his/her heart beat really fast and hard.

Review of the electronic MAR indicated Patient #10 used the Albuterol Inhaler only twice since admission, on 8/30/14 at 12:23 P.M. for shortness of breath (SOB) and again on 8/31/14 at 7:35 A.M., for SOB despite the Patient #10 telling the surveyor that the inhaler is used 2 or 3 times a day.

During interview on 9/4/14 at 9:25 A.M., Nurse Manager #3 told the surveyor that Patient #10 was not assessed for competency to self administer the Albuterol inhaler, was not instructed on the proper use of the inhaler, and was not instructed to tell staff when the medication is self administered so as to ensure the medication is not administered more often than ordered. Nurse Manager #3 also said that safe storage of the medication was not discussed with staff or the patient.

Please refer to A467.

Based on observation and staff interviews, the Hospital failed to properly maintain medical records in a location that was protected from fire and water damage. Findings include:

Closed Record Maintenance:

Observation on 9/3/14 at 9:10 A.M., of the closed medical record room in the Worcester Outpatient Clinic with the Vice President of Outpatient Services, and on 9/3/14 at 12:45 P.M., with the Hospital's Director of Medical Records, indicated multiple rows of medical records stored on metal cabinets without being totally enclosed in a cabinet. As a result, medical records were not stored so as to prevent their damage or destruction from fire or medical record room water sprinkler damage.

Both the Vice President of Outpatient Services said on 9/3/14 at 9:10 A.M. and the Director of Medical Records said on 9/3/14 at 12:45 P.M. that the current storage of medical records did not provide an effective protection of closed records if a fire occurred when Administrative staff were unavailable (such as nights and weekends.)

Based on record review, observation, and staff interview, the facility failed to ensure 2 of 30 Active Inpatient records (#9 and #20) had complete and accurate physicians' orders for medications and wound care. Findings include:

1. For Patient #9 the hospital failed to ensure the patient had complete orders for a foot wound and the anti-infective medication Bactrim according to Medication Administration Record's information to be filled in at the time of administration.

Patient #9 was admitted to the hospital on 8/31/14. Diagnoses include bipolar disorder, anxiety, pain and a recent right toe infection.

The Physician's orders of 9/2/14 stated:

- "Bacitracin (anti-infective ointment) oint 0.9 gm (grams), 1 application topical tid (three times daily)." The electronic medication administration record (MAR) indicated the Patient had the first dose applied on 9/2/14 at 2:24 P.M.

The order was not complete because it did not specify why the medication was indicated (infection), the site that the medication was to be applied (right toe), and how long the medication should be used (not stop date).

Review of the electronic MAR indicated the site as "topical." There was no documentation in the Comment/Reason section or the Reaction section.

During interview on 9/4/14 at 9:30 A.M., Nurse Manager (NM) #3 said that staff should be documenting where the Bacitracin is being applied with a description of the wound when the ointment is applied. NM #3 looked up the order and found no that evidence that the order was complete or that staff had any documentation describing the Patient's right toe wound.

Another medication order stated, "SMZ/TMP DS (anti-infective sulfonamide medication Bactrim Double Strength) 800-160 mg tab (tablet), 1 tab po (by mouth) bid (twice daily)."

The MAR indicated the first dose was administered to Patient #9 at 9:58 P.M. on 9/2/14. The order was not complete because there was no specific stop date for the medication and no explanation for its use (what the medication was indicate for) as per their policy. The MAR had documentation areas for a stop date and the reason a medication would be given, neither area was completed.

After surveyor interview on 9/2/14 at 1:30 P.M., regarding the incomplete orders, NM #3 said that as of 9/4/14, the orders were still incomplete, as discussed.


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2. For Patient #20, observations on 9/2/14 at 10:45 A.M., in the Patient's room during a dressing change, indicated that Patient #20 had two wounds; one on the right mid lower leg and one on the right lower leg closer to the foot.

Review of Physicians' Orders, indicated the following: "Bacitracin dressing right leg." The order did not indicated the type of dressing (e.g., clean versus (vs) sterile, wet vs dry), which wound (or both wounds) to apply the Bacitracin, and the frequency of the dressing change (e.g., daily, twice a day, or every other day). The order, as written, was incomplete.

During interview on 9/2/14 at 11:15 A.M., RN #3, said that the order, as written, did not give complete instructions on how to do the dressing.

Based on review of medical records and staff interview, the Hospital failed to ensure that all medical records contained documentation necessary to monitor the patient's condition relative to the use of PRN (as needed) medications for 13 of 30 active patient records reviewed (#8, #9, #10, #12, #13, #14, #15, #16, #17, #18, #19, #24, and #26). Findings include:

1. For Patient #14, the Hospital failed to document the effects of the PRN medications after administration.

Patient #14 was admitted to the Hospital on 8/29/14 with diagnoses including substance abuse and pain.

Review of the electronic MAR (Medication Administration Administration) and Patient Progress Notes from 8/29/14 through 9/2/14, indicated the effectiveness of the following PRN medications were not documented:

-30 ml (milliliters) magnesium hydroxide (for constipation) given on 8/31/14 at 8:20 A.M.;

-30 ml Gaviscon (for heartburn and/or gas) given on 9/1/14 at 4:26 P.M.;

-650 mg (milligrams) acetaminophen (for headache, fever and/or pain) given on 8/29/14 at 9:07 P.M., 8/30/14 at 9:02 A.M. and 2:22 P.M., 8/31/14 at 6:18 P.M., and 9/1/14 at 8:44 A.M., 4:26 P.M. and 9:42 P.M.;

-300 mg trimethobenzamide HCL (for nausea and/or vomiting) given on 8/29/14 at 9:07 P.M.;

-10 mg dicyclomine (for abdominal cramping) given on 8/29/14 at 9:07 P.M.; and

-50 mg chlordiazepoxide HCL (for symptoms of withdrawals) given on 8/29/14 at 7:09 P.M., 8/31/14 at 1:05 P.M. and 9/1/14 at 8:44 A.M.

2. For Patient #15, the Hospital failed to document the effectiveness of the PRN medications after administration.

Patient #15 was admitted to the Hospital on 8/30/14 with diagnoses including drug dependency, anxiety, depression and Hepatitis C.

Review of the electronic MAR and Patient Progress Notes from 8/30/14 through 9/2/14 indicated the effectiveness of the following PRN medications were not documented:

-10 mg methadone HCL (for symptoms of withdrawal) given on 8/30/14 at 7:43 P.M., and 5 mg given on 9/2/14 at 6:56 P.M. and 9/3/14 at 5:21 A.M.;

-8 mg Nicorette (for nicotine craving) given on 8/30/14 at 7:43 P.M.;

-650 mg acetaminophen (for headache, fever and/or pain) given on 8/31/14 at 1:52 P.M. and 8:22 P.M., and 9/2/14 at 6:52 P.M.;

-300 mg trimethobenzamide HCL (for nausea and/or vomiting) given on 8/31/14 at 1:52 P.M. and 9/2/14 at 6:52 P.M.;

-10 mg dicyclomine (for abdominal cramping) given on 8/31/14 at 1:52 P.M. and 9/2/14 at 4:52 P.M.; and

-0.1 mg clonidine (for elevated blood pressure/anxiety) given on 8/31/14 at 8:22 P.M., 9/1/14 at 9:00 P.M., and 9/3/14 at 12:27 P.M.

3. For Patient #16, the Hospital failed to document the effectiveness to the PRN medications after administration.

Patient #16 was admitted to the Hospital on 8/29/14 with diagnoses including alcohol dependency, HTN (hypertension), chronic pain, asthma and neuropathy.

Review of the electronic MAR and Patient Progress Notes from 8/29/14 through 9/2/14 indicated the effectiveness of the following PRN medications were not documented:

-50 mg chlordiazepoxide HCL (for symptoms of withdrawals) given on 8/30/14 at 8:17 A.M., 1:44 P.M. and 7:35 P.M., 8/31/14 at 10:29 A.M., and 75 mg given on 8/29/14 at 9:29 P.M.;

-600 mg ibuprofen (for pain) given on 8/30/14 at 8:17 A.M., 9/1/14 at 9:37 A.M. and 4:03 P.M. and 9/3/14 at 9:54 A.M.;

-2 puffs of Ventolin HFA (for impaired breathing) given on 8/30/14 at 11:51 A.M.;

-150 mg trazadone (for insomnia) given on 8/31/14 at 9:35 P.M. and 9/2/14 at 10:37 P.M.; and

-0.1 mg clonidine (for elevated blood pressure/anxiety) given on 8/31/14 at 1:02 P.M. and 9:35 P.M., 9/1/14 at 9:37 A.M. and 4:04 P.M., 9/2/14 at 9:22 A.M. and 6:19 P.M., and 9/3/14 at 9:54 A.M.

4. For Patient #17, the Hospital failed to document the reaction to the PRN medications after administration.

Patient #17 was admitted to the Hospital on 9/1/14 with diagnoses including polysubstance dependency, chronic pain and Hepatitis C.

Review of the electronic MAR and Patient Progress Notes from 9/1/14 through 9/2/14 indicated the effectiveness of the following PRN medications were not documented:

-10 mg methadone HCL (for symptoms of withdrawal) given on 9/1/14 at 3:08 P.M. and 10:23 P.M., and 9/2/14 at 8:29 A.M.; and

-800 mg ibuprofen (for pain) given on 9/3/14 at 8:42 A.M.;

5. For Patient #18, the Hospital failed to document the effectiveness of PRN medications after administration.

Patient #18 was admitted to the Hospital on 8/28/14 with diagnoses including alcohol dependency and seizure disorder.

Review of the electronic MAR and Patient Progress Notes from 8/28/14 through 9/2/14 indicated the effectiveness of the following PRN medications were not documented:

-50 mg diphenhydramine HCL (for sleep problems) given on 8/30/14 at 8:38 P.M. and 8/31/14 at 8:18 P.M.; and

-50 mg chlordiazepoxide HCL (for symptoms of withdrawals) given on 8/29/14 at 4:10 A.M., 10:42 A.M. and 1:05 P.M., 8/30/14 at 6:10 A.M. and 10:04 A.M., 8/31/14 at 10:31 A.M. and, 9/1/14 10:03 P.M.;

6. For Patient #19, the Hospital failed to document the effectiveness of PRN medications after administration.

Patient #19 was admitted to the Hospital on 9/1/14 with diagnoses including drug dependency.

Review of the electronic MAR and Patient Progress Notes from 9/1/14 through 9/2/14 indicated the effectiveness of the following PRN medications were not documented:

-650 mg (milligrams) acetaminophen (for fever, headache and/or pain) given on 9/3/14 at 8:05 A.M.; and

-50 mg diphenhydramine HCL (for sleep problems) given on 9/2/14 at 10:28 P.M.

During an interview on 9/4/14 at 10:15 A.M., the DON (Director of Nurses) said that nursing should have documented the effectiveness of PRN medications after being administered to patients. She said there is a space on the electronic MAR for this documentation and she was aware that not all nursing staff were doing this. She said the nursing staff would be re-educated regarding this issue.


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7. For Patient #8, the hospital failed to provide documentation regarding PRN medications including the effectiveness of the medication.

Patient #8 was admitted to the hospital on 8/30/14. Diagnoses include pain, and sleep disturbance.

Review of the electronic MAR and Patient Progress Notes from 8/30/14 to 9/3/14 indicated that nurses did not document the effect of PRN medications that were administered on the following dates:

- Tylenol (pain reliever) 650 milligrams (mg) PRN every 4 hours for pain. No effect documented on 8/30/14, 8/31/14, 9/1/14, 9/2/14 (2 doses).
- Kaopectate (antidiarrheal) 30 milliliters (ml) PRN diarrhea one time dose. No effect documented on 8/30/14.
- Tigan (anti-nausea/vomiting) 300 mg. by mouth PRN every 4 hours. No effect documented on 8/30/14 (twice), 8/31/14, 9/1/14 and 9/2/14.
- Benadryl (used to enhance sleep) 50 mg. PRN at bedtime. No effect documented on 8/31/14, 9/1/14 and 9/2/14.
- Bentyl (used for abdominal cramping) 10 mg. PRN four times daily. No effect documented on 9/1/14.
- Methocarbamol (muscle relaxant used for pain) 750 mg. PRN 3 times a day. No effect documented on 8/31/14, 9/1/14 (2 doses), 9/2/14 (2 doses) and 9/3/14.

8. For Patient #9, the hospital failed to provide documentation regarding PRN medications including the effectiveness of the medication.

Patient #9 was admitted to the hospital on 8/31/14. Diagnoses include pain, sleep disturbance, bipolar disorder and anxiety.

Review of the electronic MAR and Patient Progress Notes from 8/31/14 to 9/3/14 indicated that nurses did not document the effect of PRN medications that were administered on the following dates:

- Tigan 300 mg. PRN every 4 hours. No effect documented on 9/2/14.
- Bentyl 10 mg. cap, 50 mg. PRN every 4 times daily for cramping. No effect documented on 9/2/14.
- Motrin (pain reliever) 600 mg. PRN 4 times daily for pain. No effect documented on 8/31/14, 9/1/14 and 9/2/14.
- Seroquel (anti-psychotic) 50 mg. PRN 4 times daily for anxiety. No effect documented on 8/31/14 and 9/2/14.
- Catapres 0.1 mg. (anti-hypertensive given for anxiety) PRN every 4 hours. No documented effect on 9/3/14.

9. For Patient #10, the hospital failed to provide documentation regarding PRN medications including the effect the medication had.

Patient #10 was admitted to the hospital on 8/29/14. Diagnoses include pain, sleep disturbance, asthma, depression, and anxiety.

Review of the electronic MAR and Patient Progress Notes from 8/29/14 to 9/3/14 indicated that nurses did not document the effect of PRN medications that were administered on the following dates:

- Benadryl (for sleep enhancement) 50 mg. PRN at bedtime. No documented effect on 9/3/14.
- Librium (for anxiety) 50 mg. Given one time on 8/30/14 with no effect documented.
- Seroquel (antipsychotic) 50 mg. PRN at bedtime. Given on 8/30/14 with no reason why it was given and documented effect. In the reason section was documented "other."
- Albuterol Inhaler (bronchospasm inhalant) 2 puffs PRN 4 times daily. No documented effect on 8/31/14.
- Motrin 600 mg. PRN every 6 hours for pain. No documented effect on 8/30/14 and 2 doses on 9/2/14.
- Flexeril (muscle relaxant) 10 mg. PRN 3 times a day. No effect documented for 2 doses on 9/2/14.

10. For Patient #12, the hospital failed to provide documentation regarding PRN medications including the effect the medication had.

Patient #12 was admitted to the hospital on 8/28/14. Diagnoses include pain, sleep disturbance, chronic obstructive pulmonary disease, depression, and anxiety.

Review of the electronic MAR and Patient Progress Notes from 8/28/14 to 9/3/14, indicated that nurses did not document the effect of PRN medications that were administered on the following dates:

- Tylenol 650 mg. PRN every 4 hours for pain. No documented effect on 8/31/14, 9/1/14 (twice), and 9/2/14.
- Benadryl 50 mg. PRN at bedtime for sleep. No documented effect on 8/29/14, 8/30/14 and 9/1/14.
- Aspirin (pain reliever) 650 mg. alternate with Tylenol every 4 hours PRN pain. No documented effect on 8/29/14.
- Catapres 0.1 mg. (for anxiety) PRN every 4 hours. No documented effect on 8/30/14, 8/31/14, and 9/1/14.
- Flexeril (muscle relaxant) 10 mg. PRN 3 times daily. No documented effect on 8/31/14, 9/1/14 (2 doses) and 9/2/14 (2 doses).
- Oxycodone (narcotic pain reliever) 5 mg. PRN 4 times daily. No documented effect on 9/1/14 (2 doses), 9/2/14 (3 doses), and 9/3/14.

11. For Patient #13, the hospital failed to provide documentation regarding PRN medications including the effect the medication had.

Patient #13 was admitted to the hospital on 9/1/14. Diagnoses include pain, sleep disturbance, asthma, depression, and anxiety.

Review of the electronic MAR and Patient Progress Notes from 8/28/14 to 9/3/14 indicated that nurses did not document the effect of PRN medications that were administered on the following dates:

- Klonopin (anti-convulsant used for anxiety), 1 mg. PRN 4 times daily for anxiety. No documented effect on 8/28/14, 8/29/14 (4 doses) and 8/30/14.
- Seroquel (antipsychotic used for sleep). No documented effect on 8/29/14, 8/30/14 and 8/31/14.
- Doxepin (anti-convulsant used for anxiety) 50 mg. PRN at bedtime. No documented effect on 8/29 (2 doses), 8/30/14, 8/31/14 and 9/1/14.
- Catapres (for anxiety) PRN at bedtime, 0.2 mg. No documented effect on 8/28/14, 8/31/14 and 9/2/14.

During interview on 9/4/14 at 1:35 P.M., Nurse Manager #3 said that she was unaware that nurses were not documenting the effects of PRN medications. She said that there would have to be some education done.



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12. For Patient #24, review of the MAR indicated that Patient #24 received the PRN medication Gaviscon (antacid), 30 milliliters (mls) on 8/30/14 at 4:40 P.M., on 8/31/14 at 12:06 P.M., and on 9/2/14 at 11:46 A.M. Further medical record review indicated that neither the MAR nor Nurses' Notes contained documentation that indicated an evaluation of the effect of the Gaviscon.

13. For Patient #26, review of the MAR indicated that Patient #26 received the following PRN medications, for which no assessment of the medications effectiveness was documented.

On 9/1/14 at 10:43 P.M., the medication Tylenol was administered for a pain score of 8 of 10, with 10 being the most severe. Medical record review indicated that neither the MAR nor Nurses' Notes contained documentation that indicated an evaluation of the effect of the Tylenol.

On 9/1/14 at 10:43 P.M. and on 9/2/14 at 7:40 A.M., Patient #26 was administered a Lidocaine (topical anesthetic) patch for a pain score of 8 of 10, with 10 being the most severe. Review of the MAR and Nurses' Notes indicated that they lacked documentation of an evaluation of the effect of the Lidocaine patch.

14. During an interview on 9/3/14 at 9:45 A.M., RN #7 said that it was not Hospital nursing practice to document the effect of PRN medications and that the effectiveness of PRN medications should be documented.

Based on observation, record review and interview the pharmaceutical services failed to meet the needs of patient's related to safe medication storage, verification, administration and following the manufacturer's directions for use (MDFU) of the electronic medication administration scanning system. The Pharmaceutical Services were not coordinated in a manner to ensure the safety of patients and utilize data to minimize medication errors. In addition, the Hospital failed to ensure that staff followed Hospital policy for not accepting verbal orders and for not administering a medication at the appropriate time in relation to meals. Findings include:

1. Adequate patient safety practices were not followed for medication administration, verification and storage for medications which the patients brought from their homes to prevent medications errors.

a. Observation during a medication pass on 9/2/14 at 9:20 A.M. and at 9:25 A.M., indicated medications the patients brought from their homes lacked safe practices to prevent medications errors. Strips of preprinted medication labels meant to be affixed to individual prescription bottles were stored on top of multiple prescription bottles from the patient's community pharmacies. During the medication pass, these strips of labels, which were not affixed to the medication bottles, were entered into the electronic medication administration record by a scanning device. This process bypassed the safety feature of having labels, containing the bar code that identified the name of patients' medications, affixed to the specific prescription medication containers.

b. Review of the Nursing and Pharmacy policies indicated there were no policies for medication administration, verification or storage of medications when patients' brought their prescription medications to the Hospital from their homes. The manufactures guidelines for the electronic medication verification system was not followed. During the medication passes the verification process for preventing medication errors was bypassed.

c. During an interview with the Director of Nurses on 9/3/14 at 1:10 P.M., she said that there were no written policies or procedures for the nurses to follow for patients who bring their medications from home regarding medication administration, verification or storage.

Please refer to A490 and A500.

2. Review of the Executive Committee of the Medical Staff minutes on 9/4/14, indicated that Nurses accepting verbal orders from the Physicians in nonemergent situations was not an acceptable practice and continued to be a problem for the Hospital.

a. For Patient #27, the Hospital staff failed to adhere to the Hospital's policy for not taking or writing verbal orders except in emergency situations. Based on review of Hospital's policies and interview with Nurse Manager (NM) #3 on 9/2/14 at 2:50 P.M. and interview with the Director of Nurses on 9/3/14 at 1:10 P.M., the hospital staff are not allowed to take verbal orders. During an interview, on 9/2/14 at 12:10 P.M., NM #3 stated that she accepted a verbal order for Patient #27 for Coumadin (blood thinning medication) during rounds that morning.

b. The Hospital failed to follow the State Board of Registration in Nursing Regulations [244 CMR 9.03(38)], related to Administration of Drugs, "A nurse licensed by the Board shall not administer any prescription drug or non-prescription drug to any person in the course of nursing practice except as directed by an authorized practioner."

b. Review of the Executive Committee of the Medical Staff Minutes of 11/25/13 indicated a Nurse Practitioner gave a verbal order to the Charge Nurse for the medication Phenobarbital (prevents seizures). The Charge Nurse then passed the verbal order along to another nurse, who administered the Phenobarbital to the wrong patient.

Please refer to A407.

3. The Hospital failed to ensure staff administered a proton pump inhibitor (PPI) medication for gastroesphageal reflux disorder (GERD) at the appropriate time in relation to meals. Observation during a medication pass on 9/2/14 at 9:20 A.M., for Patient #6, with diagnoses of GERD and gastric bypass surgery, was given the PPI 50 minutes after starting breakfast.

a. Review of the medication manufacturer's directions for use (MDFU) indicated that the PPI medication was to be administered one hour before meals. The PPI blister pack was not labeled to be administered one hour before meals per MDFU, nor was there a note on the medication administration record (MAR) to that effect.

b. Review of the Quality Environment/Safety Committee minutes on 9/3/14, indicated there were medication errors with the bar codes (related to "bad scans") for medications. This system had been implemented in 2012 with the electronic medical record.

Please refer to A405.

4. The Hospital failed to ensure that a supervising Pharmacist provided comprehensive, coordinated Pharmaceutical Services that ensured the safety of current patients and utilized data to proactively minimize medication errors for future patients.
A review of Nursing medication use policies did not reflect Pharmacy involvement in the development of these policies. Nursing assumed responsibilities (e.g., verification of patients own medication with retail pharmacies) that are the responsibility of a pharmacist as follows:
a. The High Risk Medication Policy did not identify Hospital practices designed to minimize risk.
b. Pharmacy policies did not address drug-utilization and formulary initiatives that optimized therapeutic outcomes, and reduced the risk of drug-related problems.
c. Review of Pharmacy documentation indicated that the Hospital lacked proactive oversight by a pharmacist to monitor, track and trend the use of controlled substances for effectiveness and to prevent diversion and/or tampering.
d. Review of Pharmacy performance improvement, indicated that the quarterly review of medication errors lacked drug names that would allow trending and tracking the effect of error minimization strategies.

Please refer to A492.

Based on observations, a review of policies, and interviews, the Hospital failed to ensure that a supervising Pharmacist provided comprehensive, coordinated Pharmaceutical Services that ensured the safety of current patients and utilized data to proactively minimize medication errors for future patients.
The American Society of Health-System Pharmacists (ASHP) Statement on the Roles and Responsibilities of the Pharmacy Executive states that "The pharmacy executive ensures that the medication-use system is continuously evaluated and improved using contemporary quality-improvement methods. The pharmacy executive (or his or her designee) should be a member of all of the institution's key committees responsible for performance-improvement activities related to medication use and patient safety.
The pharmacy executive collaborates with peers to develop drug-utilization and formulary initiatives that optimize therapeutic outcomes, reduce the risk of drug-related problems, and ensure the use of cost-effective pharmacotherapy throughout the health system.

1. During an interview in the Pharmacy on 9/2/14 at 10:30 A.M., the Director of Pharmacy said that Pharmaceutical Services at AdCare Hospital were an aggregate of three (3) components:
(1) stock medications that the in-house pharmacy provided (unit-dose tablets and liquids used primarily for detoxification),
(2) patients' own medications from home (that Nursing confirms with the dispensing retail pharmacy and subsequently approved by the AdCare prescriber), and
(3) patient specific medications, which are supplied by the Contracted Pharmacy in blister pack cards.
The Contracted Pharmacy also supplies emergency kits and kits of other medications.
The in-house Director said that he works 2-3 hours per shift on Monday, Wednesday, and Friday; other part-time pharmacists work weekends. Other than the hours staffed by the Pharmacy Director and week-end pharmacists, there was no on-site pharmacy back-up to address immediate pharmacy needs, e.g., bar codes that will not scan for Nurses or Performance Improvement initiatives.
The Director was primarily responsible for the purchase and distribution of stock medications, including controlled substances. Those functions were performed well and detailed records were maintained.
2. A review of Nursing medication use policies did not reflect Pharmacy involvement in the development of these policies. Nursing assumed responsibilities (e.g., verification of patients own medication with retail pharmacies) that are the responsibility of a pharmacist as follows:
a. The High Risk Medication Policy listed the high risk medications (insulins, Methadone, potassium chloride) but did not identify Hospital practices designed to minimize risk.
b. Pharmacy policies did not address drug-utilization and formulary initiatives that optimized therapeutic outcomes, reduced the risk of drug-related problems, and ensured cost-effective therapy.
c. Review of Pharmacy documentation indicated that the Hospital lacked proactive oversight by a pharmacist to monitor, track and trend the use of controlled substances for effectiveness and to prevent diversion and/or tampering.
d. Review of Pharmacy performance improvement, indicated that the quarterly review of medication errors lacked drug names that would allow trending and tracking the effect of error minimization strategies.

Based on observation, record review and interview the Hospital failed to provide adequate patient safety with medication administration, verification and storage during a medication pass on 2 of 3 medication passes. Findings include:

According to the manufacturers guide for the medication verification system used for their electronic medication administration record it stated, "(Company name) developed Medication Administration Verification - a fully integrated and wireless point of care method for safer medication administration. To perform a verification, the patient's armband is scanned first and then the medication. The system then compares the medication to the patient's medication profile of outstanding orders ensuring that the specific medication and dosage was in fact ordered for the patient. In the event a corresponding medication order is not found for the patient, the system will return a message indicating that a potential error is about to occur."

1. Patient #6 was admitted 9/1/14 at 4:50 P.M. with alcohol and benzodiazepine abuse.

During a medication pass on 9/2/14 at 9:20 A.M. on Unit 4 East with Surveyor #1, Licensed Practical Nurse (LPN) #1, scanned Patient #6's wrist band and poured this Patient's 8:00 A.M. medications. The Zoloft 100 milligrams (mg.) by mouth (an antidepressant medication), the Propranolol (Inderal, a beta blocker, antihypertensive medication) 40 mg. by mouth, Vitamin B 12 100 micrograms by mouth, and Folic Acid 1 mg. by mouth were taken from prescription bottles brought from this patient's home. There were no bar codes attached to the 4 bottles of medication from this patient's home. The verification process was bypassed because the label with the bar code to indicate that this was the correct medication, dosage and route for this patient was not attached to the medication bottle.

With no bar codes on the bottles to scan, LPN #1 scanned 4 medication labels which were not affixed to the containers of medication. These labels were on a strip of preprinted medication labels sitting on top of approximately 8 medication bottles located in a large plastic bag in the bottom drawer of the medication cart. LPN #1 said that these labels had been printed out last night by the Nurses with orders approved by the Physician. LPN #1 said that this Patient came in last evening, and at that time they gave the medication that the patient had brought from home, and this morning they will give the medication that the patient had brought from home. This would occur until Pharmacy can fill the doctor's ordered prescriptions, which she said would be later that morning.

Surveyor #1 asked, "Do the Patient's medications go to Pharmacy to be verified that the correct medications are in the bottle before they are administered?" She said, "No, we type in the labels and print them." LPN #1 administered the the following medications to this patient: Zoloft 100 mg by mouth, Inderol 40 mg. by mouth, Vitamin B 12 100 micrograms by mouth, and Folic Acid 1 mg.

2. Patient #7 was admitted 8/27/14 with alcohol abuse, cardiomegaly, anxiety and depression.

During a medication pass on 9/2/14 at 9:25 A.M. on Unit 4 East with Surveyor #1, LPN #1 scanned Patient #7's wrist band and poured this Patient's 8:00 A.M. medications. LPN #1 said that the Bupropion 150 mg extended release by mouth (an antianxiety medication) had not been restocked because of the holiday. So she opened the bottom drawer of the medication cart, and removed a large plastic bag with multiple bottles of prescriptions from the patient's home, along with a strip of multiple, pre-printed medication labels which were located on top the Patient's bag of medication bottles. She scanned one of the medication labels from the strip. She opened one of the medication bottles and administered the Buproprion medication. This bypassed the safety feature which was intended to have the bar code label affixed to the specific prescription medication container, and not a strip of medication labels placed above multiple bottles of prescriptions, stored in a large bag.

3. During an interview with the Director of Nurses (DON) on 9/3/14 at 1:10 P.M., she said that when the Patients bring medications from home, the Nurses verify the medications are the correct medications before administering them. The Surveyor asked the DON, "Do you have a hospital policy regarding the medication verification process performed by the Nurses?" The DON said, "No." The Surveyor asked, "Do you have a policy on how the Nurse's should administer medications from home that do not have a bar code affixed to them (as per the manufacturers guidelines to prevent errors)?" The DON said, "No." The Surveyor asked, "Is it the Hospital policy to store multiple medications bottles in large plastic bags in the medication cart?" The DON said, "No, they should be stored in the medication rooms."

4. Review of the Quality Environment/Safety Committee minutes on 9/3/14, indicated there were medication errors with the bar codes (related to "bad scans") for medications. This system had been implemented in 2012 with the electronic medical record.

Based on observations, interviews, and document review, the condition of the physical plant and the overall hospital environment was not maintained in such a manner that the safety and well-being of patients were assured. Findings include:

1. Observation of the 2 West Unit's Clean Supply Room on 9/2/14 at 9:00 A.M., indicated the following items were stored directly on the floor:
-Three cartons of 90 disposable drinking cups;
-Two cartons of 50 disposable water pitchers;
-Four cartons of cold compresses; and
-Two cartons of disposable scrub pants.

Interview with Licensed Practical Nurse (LPN) #2, during the observation, indicated that Hospital policy prohibited items from being stored directly on the floor.


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2. The Dietary Department failed to ensure that adequate physical environment was maintained in the Kitchen. Findings include:

Review of the Hospital's Cleaning Policy (IC.4) with a revision date of 9/15/13, indicated the following:

-The purpose: To maintain a sanitary work environment.
-The procedure: Equipment, work surfaces, walls and floors are maintained in sanitary conditions by daily on-going procedures.
-Training is provided to appropriate personnel regarding correct procedure, cleaning agents and frequency of all areas of the Department.

During an initial tour of the Dietary Department on 9/2/14 at 9:45 A.M., the following concerns were observed;

-The floor in the room containing juice boxes (used for the dispensing machine) was dirty with food particles and had beverage service equipment stored directly on the floor.
-A wall behind and the floor under the grill was dirty with grease and dried food particles.
-The floor under the cook's prep area was littered with several pieces of dried food particles.

3. During a second tour of the Dietary Department on 9/3/14 at 11:45 A.M., the following concerns were still observed:

-The floor in the room containing the juice boxes remained dirty and the beverage service containers remained directly on the floor.
-The floor under, and the wall behind the grill were still dirty with grease and dried-on food particles.
-The floor under the cook's prep area remained littered with several pieces of dried food particles.

4. The Food Service Director (FSD) and the Regional Manager for the Food Service Management Company said the areas of concern would be addressed and cleaned.

Based on record review the Hospital failed to maintain and monitor supplies and equipment related to ensuring test strips for monitoring urine toxicology were tested for quality and not beyond their use date, calibrating the breathalyzer for accuracy, and checking the code cart equipment and supplies on a scheduled basis. Findings include:

According to the manufacturer's guidelines for testing reagent strips for urine toxicology, it indicated to test positive and negative quality controls when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days.

According to the manufacturer's guideline for the handheld breath alcohol device designed to estimate blood alcohol concentration, for instrument quality control to produce accurate results, the unit must be in calibration.
The accuracy of an instrument is verified by running a known alcohol concentration (standard) through the sampling system and verifying that the result is within an acceptable tolerance of the expected or target value of the standard.

1. During observation in the patient bathroom of the Outpatient Worcester Satellite on 9/3/14 at 8:45 A.M., Surveyor #1 observed the following:

- An opened undated bottle of reagent strips used (approximately 1/4 full of strips) for testing the urine specimen for its pH and temperature. If undated it is considered outdated.

- A handheld breathalyzer with no documentation of the date it was calibrated.

Interview with the Vice President of Outpatient Services on 9/3/14 at 9:30 A.M., he indicated that the bottle of reagent strips was not dated when opened and that there were no test sheets to indicate the quality controls for testing the strips when opened and every 30 days.

Interview with the Director of Facilities Management on 9/2/14 at 3:45 P.M., he stated that the breathalyzer had not been calibrated but will be in the future.


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2. Review of Code Cart Inspection Logs from 12/29/13 to 8/22/14, on the 2 West Unit on 9/2/14, indicated that weekly code cart inspections were not consistently performed, as required by Hospital policy. The inspections were missed on following dates:

8/3/14; 7/20/14; 7/6/14; 6/22/14; 6/15/14; 5/4/14; 4/20/14; 4/13/14; 3/30/14; 3/23/14; 3/2/14; 2/23/14; 2/9/14; 1/5/14; 12/29/14.

Interview with Licensed Practical Nurse (LPN) #2 on 9/2/14 at 10:45 A.M., indicated that policy required that the code carts were to be inspected weekly, by the 11:00 P.M. to 7:00 A.M. staff. LPN #2 said that the inspections were not performed, as required.

Review of Quality Treatment Committee meeting minutes dated 2/11/14, indicated that the 2 East Unit missed code cart checks on 1/17/14 and the 3 East Unit missed the code cart check on 1/3/14.

Review of Quality Treatment Committee meeting minutes dated 4/8/14, indicated that two code carts on the 2 East Unit missed code cart checks.

Based on observation, documentation review and interview, the Hospital failed to ensure that freezer temperatures were routinely monitored for adequacy in the nourishment kitchens, and appropriate freezer temperatures were consistently maintained in the Dietary Department. Findings include:

Review of the Hospital's Temperature Log Policy (PI.3, IC.4) with a revision date of 9/15/13 included the following;

-The purpose is to ensure that the equipment is working properly and prevent potential food-borne illnesses.
-The procedure is to record temperatures of all refrigerator/freezer equipment daily.
-Freezer temperatures need to be less than 10 degrees F (Fahrenheit).

Nourishment Kitchens:

1. During an initial tour of Unit 2 West at 8:30 A.M., surveyor #2 observed the freezer in the nourishment kitchen. There was no thermometer in the freezer and there was no record of freezer temperatures.

2. During a second tour of all the nourishment kitchens (2 West, 3 East and 4 East) with the Food Service Director (FSD) on 9/4/14 at 8:10 A.M., no thermometers were observed in any of the freezers.

Review of the Hospital's Daily Temperature Logs for July, August and September 2014 indicated that only the refrigerator temperatures were recorded twice daily, for each nourishment kitchen.

During an interview on 9/4/14 at 8:30 A.M., the FSD said that the temperatures of the freezers in the nourishment kitchens were never recorded.

Review of the Hospital's Daily Temperature Logs for July and August 2014 indicated the following days with freezer temperatures above the policy's required below 10 degrees F:
-7/6/14 A.M. 40 degrees F,
-8/9/14 P.M. 15 degrees F,
-8/10/14 A.M. 18 degrees F,
-8/13/14 P.M. 15 degrees F,
-8/23/14 P.M. 22 degrees F,
-8/25/14 P.M. 22 degrees F,
-8/29/14 P.M. 29 degrees F.

On 9/3/14 at 11:45 A.M., surveyor #2 observed the freezer temperatures were 24 degrees F on both the equipment's thermometer outside and inside the freezer.

On 9/4/14 at 8:10 A.M., surveyor #2 observed the freezer temperatures were both 32 degrees F on both the equipment's thermometer outside and inside the freezer.

During an interview with surveyor #2 on 9/4/14 at 8:15 A.M., the Director of Facilities said the freezer would be inspected today to determine why the temperatures was elevated. He said that they should not be that high.

On 9/4/14 at 11:20 A.M., surveyor #2 observed the freezer temperatures were 20 degrees F on the equipment's thermometer outside the door and 14 degrees F on the thermometer inside the freezer.

During an interview with surveyor #2 on 9/4/14 at 11:20 A.M., the FSD said that the freezer temperature remained above the Hospital policy's required temperature of below 10 degrees F.

Based on observations, staff interviews, review of the Hospital's policies/procedures, review of the Centers for Disease Control (CDC) and Prevention Infection Control (IC) Standards for Hand Hygiene, review of the Hospital's Exposure Control Plan, and review of manufacturer's directions for use (MDFU), the Hospital failed to consistently ensure staff adherence to Infection Control Standards for 2 Inpatients (#20, #24), from a sample of 30 Active Inpatients. Findings include:

1. Observations of the of the patient refrigerator on the 2 West Unit at 9:30 A.M. on 9/2/14, indicated a temperature monitoring sheet attached to the right side of the refrigerator. Review of the temperature monitoring sheet indicated that only the refrigerator temperatures and not the freezer temperatures were being documented daily. Six, half-gallon containers of ice cream were stored in the patient refrigerator freezer.

Interview with LPN #2 during the observation, indicated that Dietary staff were responsible to monitor refrigerator temperatures daily, and that freezer temperatures were not regularly monitored. LPN #2 said he never observed refrigerator freezer temperatures being monitored.

During interview on 9/4/14 at 10:00 A.M., the the Facilities Director said that the freezer temperatures in patient refrigerators were not monitored.

2. Review of the MFDU for the disinfectant Virex on 9/3/14, indicated that for proper disinfection to occur the surface being disinfected must be visibly wet for 10 minutes.

a. Observation on 9/2/14, on the 2 West Unit at 9:30 A.M., indicated that Housekeeper #2 wiped the door handle to the patient bathroom with Virex. The door handle was not visibly wet for 10 minutes.

b. Observation on 9/3/14 at 10:00 A.M., in the 2 West Unit's Charting Room, indicated that Housekeeper #2 disinfected the counter with Virex. The counter was not visible wet for 10 minutes.

c. Interviews with the Director of Facilities and the Housekeeping Supervisor on 9/3/14 at 3:30 P.M., indicated that they were not aware of the Virex MDFU requirement that surfaces being disinfected must be visibly wet for 10 minutes.

3a. Centers for Disease Control and Prevention (CDC) indications for hand hygiene include:

- Before and after contact with a patient's intact skin (e.g., taking a pulse or blood pressure, performing physical examinations, lifting the patient in bed);

- Before and after contact with environmental surfaces in the immediate vicinity of patients; and

- Before and after glove removal.

b. Review of the Hospital's policy titled "Wound Care: Dressings" on 9/3/14 read,

-All dressings and other supplies and equipment must be sterile to minimize chances of infection.

-Strict handwashing is absolutely necessary before donning sterile gloves.

-Sterile gloves should be worn to: remove soiled dressing; cleanse the wound with sterile solution; and to apply sterile dressing.

c. For Patient #20, observation of a dressing change in the patient's room on 9/2/14 at 10:40 A.M., indicated that Registered Nurse (RN) #3, failed to follow Hospital policy and CDC Hand Hygiene Guidelines as follows:

-RN #3 opened and donned sterile gloves without first performing hand hygiene;

-RN #3 then touched the outside, unsterile wrappers of her dressing supplies (e.g., 2x2 sponges, q tips, Kling wrap, telfa (non-adhering) pad), contaminating her sterile gloves (RN #3 did not change her gloves after touching unsterile outer wrappers);

-With the same contaminated gloves and using the glove wrapper as her sterile field, RN #3 opened each of the dressing supplies, contaminated the sterile supplies by opening them with now unsterile gloves, and opened the items onto the glove wrapper.

-Still wearing the contaminated gloves, RN #3 then touched a small bottle of normal saline solution. RN #3 then proceeded to pour the solution onto Patient #20's right shin, using a small bowl to unsuccessfully contain the solution in the bowl. The solution dripped down Patient #20's leg. Patient #20 then suggested that RN #3 place a towel under the leg to protect the bed from getting wet.

-Still wearing the same contaminated gloves, RN #3 then used the now contaminated dressing supplies and dressed Patient #20's wound.

RN #3 did not perform hand hygiene and don new sterile gloves between any of the above steps, as required by Hospital policy and CDC standards.

Interview with the Infection Control Officer (ICO) on 9/3/14 at 1:30 P.M., indicated that the ICO did not periodically observe staff infection control competence for sterile technique. The ICO said he only observed periodic hand hygiene practices.

4. For Patient #24, observations in the Patient's room on 9/3/14 at 9:55 A.M., indicated that Nurse Practitioner #1, failed to disinfect her stethescope prior to placing the stethescope on Patient #24's back to assess Patient #24's lungs, as required by Hospital policy.

Interview with the Medical Director on 9/4/14 at 2:00 P.M., indicated that Hospital policy required staff to disinfect stethescopes with an alcohol prep pad prior to and after patient use.


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5. The Dietary Department failed to ensure that adequate sanitary practices were in place to minimize the risk of food-borne illnesses. Findings include:

a. Review of the Hospital's Cleaning Policy (IC.4) with a revision date of 9/15/13, indicated the following:

-The purpose: To maintain a sanitary work environment.
-The procedure: Equipment, work surfaces, walls and floors are maintained in sanitary conditions by daily on-going procedures.
-Training is provided to appropriate personnel regarding correct procedure, cleaning agents and frequency of all areas of the Department.

b. During an initial tour of the Dietary Department on 9/2/14 at 9:45 A.M., the following concerns were observed:

-A bucket of sanitizing solution used to clean counter tops was tested and indicated it was at 10 ppm (parts per million), below the required concentration of 100 ppm.
-A fan in the an area of food service was dusty and dirty.
-A dietary aide was observed portioning jello into dessert dishes using his gloved hand instead of a serving utensil.

6. During a second tour of the Dietary Department on 9/3/14 at 11:45 A.M., the following concerns were still observed:

-The fan near the food service area was on and blowing directly over an area where food was be served. The fan was still dusty and dirty; and
-A bucket of sanitizing solution stored near the cook's prep area was tested and indicated it was at 10 ppm, which was below the required concentration of 100 ppm.

7. During an interview on 9/3/14 12:15 P.M., the Food Service Director (FSD) said that the sanitizing solution was not at the appropriate concentration and he would re-educate the staff regarding the appropriate way to mix the solution.

The FSD and the Regional Manager for the Food Service Management Company said that the other areas of concern would be addressed and cleaned to minimize the potential risk of food-borne illnesses.