The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

GEISINGER-COMMUNITY MEDICAL CENTER 1822 MULBERRY STREET SCRANTON, PA 18510 June 13, 2012
VIOLATION: MEDICAL STAFF - BYLAWS AND RULES Tag No: A0048
Based on review of the governing body bylaws, medical staff bylaws, and interview with facility staff (OTH), it was determined the facility failed to ensure the medical staff bylaws were reviewed annually.

Findings include:

Review of the facility's "Governing Body Bylaws," dated last reviewed February 2012, revealed "... Article VIII Medical and Dental Staff ... 8.03 Staff Bylaws. The Staff Bylaws shall be formulated by the Staff, in consultation with the Medical Executive Committee, and shall be effective when approved by the Board of Directors. The Staff Bylaws (and any amendments thereto when approved by the Board of Directors) shall be binding upon all members of the Staff. The President shall review the Staff Bylaws at least annually in consultation with the Staff, and shall report the results of such review to the Board of Directors. ... "

Review of the facility's "Medical Staff Bylaws," last reviewed March 10, 2010, revealed "... Article 19 - Review, Revision and Amendment to the Bylaws and Rules and Regulations 19.1 Medical Staff responsibility. The Medical staff shall have the responsibility to formulate, review annually, adopt and recommend to the Board, medical staff Bylaws and amendments in support of the purposes of the Medical Staff."

Review of medical staff bylaws and rules and regulations revealed the last review date was March 10, 2010.

Interview with EMP1 on June 12, 2012 confirmed that the medical staff rules and regulation were not reviewed annually.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the facility medical staff bylaws, medical staff rules and regulations, medical records (MR), and interview with facility staff (OTH), it was determined the facility failed to ensure the medical staff provided adequate oversight of the patient care provided by House Staff for one of ten medical records reviewed (MR1).

Findings include:

Review of the facility's "Medical Staff Bylaws," dated last reviewed March 2010, revealed "... Article 5 - Categories of the Medical Staff ... 5.7 House Staff House Staff shall consist of Residents and fell ows. House Staff are not eligible to be Members of the Medical Staff and are not eligible for delineation of Clinical Privileges, and are authorized to provide care to patients at CMC [Community Medical Center] only under appropriate supervision provided by a Practitioner who is a member of the Medical Staff. The Practitioner supervising House Staff is responsible for the care provided by House Staff and the management and care of each patient that is evaluated by House Staff is the responsibility of the supervising Practitioner. Documentation completed by House Staff Must be countersigned by the supervising Practitioner, who shall be responsible for the completeness and accuracy of medical record documentation by House Staff."

Review on June 18, 2012, of the facility's "Medical Staff Rules and Regulations," dated last reviewed March 2012, revealed "Section: Medical Staff Subject: Residents/fell ows Participation in Clinical Activities ... All resident care is supervised and the attending Physician is ultimately responsible for the care of the patient. The proximity and time of supervision, as well as the specific task delegated to the resident physician depend on a number of factors including, the level of training (i.e.,year in residency)of the resident; the skill and experience of the resident with the particular care situation; the familiarity of the supervising physician with the resident's abilities; and the acuity of the situation and the degree of risk to the patient. The Board of Directors is responsible for the quality of care the hospital provides. To carry out this responsibility, the Board of Directors provides for the effective functioning of activities related to professional graduate education."

Review of MR1 revealed an admitted [DATE], from a personal care home. The medication reconciliation record revealed the following medications were ordered by OTH1: Clozaril (an anti-psychotic) 25 mg. PO (orally) TID (three times a day), Clozaril 100 mg. at bedtime, Xanax (a benzodiazepine--psychoactive drug) 0.5 mg. PO at bedtime, Lithium (used to treat manic behavior) 300 mg. PO at bedtime, Namenda (an Alzheimer medication) 10 mg. PO daily, Aricept (a medication for dementia) 10 mg. PO daily, K-Dur (a potassium replacement) 20 mg. PO daily, Lasix (a diuretic) 40 mg. PO daily, glucotrol XL (used to control blood sugar) 2.5 mg. PO daily, Ambien (a sedative) 10 mg. PO daily, Seroquel(used to treat Schizophrenia and Bipolar disorders) 300 mg. PO at bedtime, Celexa (used to treat depression) 20 mg. PO at bedtime, Ventolin (a bronchodilator) 2 puffs QID (four times a day), Xanax 2 mg. PO TID, Neurontin (used to treat nerve pain), Oxycontin (a narcotic) 80 mg. PO q (every) 8 hrs., Enablex (used to treat an overactive bladder) 7.5 mg. PO daily, Voltaren (an anti-inflammatory medication) 50 mg. PO BID (two times a day), Lactaid (used to neutralize lactic acid) 2 tabs PO daily, Pepcid (used to treat heartburn and ulcers) 20 mg. PO TID, Ferrous Sulfate (an iron replacement) 325 PO daily, Tylenol (a pain reliever and also used to reduce fever) 325 mg. PO QID, PRN (as needed) for fever.

The Pepcid, Voltaren, K-Dur, Lasix and Glucotrol were discontinued.

All the other medications were continued. Further review of MR1 revealed there were two medication sheets sent from the personal care home. One medication sheet was for MR1. The other medication sheet belong to another patient (PT1) at the personal care home. Review of the medication sheets in MR1 sent by the personal care home revealed the Ambien, Seroquel, Celexa, Ventolin, Xanax 2 mg. TID, Ventolin, Neurontin and Oxycontin were ordered at the personal care home for PT1. The name of PT1 appeared at the bottom of the medication sheet sent by the personal care home.

The addition of these medications for PT1 to MR1 resulted in 47 medication errors occurring during the admission of MR1 at Community Medical Center.

Further review of MR1 revealed a Rapid response (A team called to respond quickly to failing patients in and out of the ICU before their condition worsens) was initiated on the patient to lethargy on June 4, 2012, at 12:00 noon. At that time, the Xanax 0.5 mg. TID was held due to excess sedation. Further review revealed the patient underwent an endoscopic procedure on June 5, 2012. The patient was administered 40 mg. of Diprivan (an anesthetic used to produce relaxation or sleep before or during surgery). The patient became difficult to arouse, required Narcan (an opoid reversal agent) times two, and was ultimately transferred to the Intensive Care Unit. At this time, the Celexa, Clozaril, and Xanax were discontinued. The Oxycontin was lowered to 40 mg. PO BID. The Neurontin was lowered to 300 mg. PO TID.

Interview with OTH1 at approximately 11:30 AM on June 12, 2012, confirmed that if the patient was demented and if the patient was on the drugs prior to admission they would continue the medications. OTH1 stated it was not unusual to see this number of medications and at that doses noted above in a patient with dementia. OTH1 also confirmed the patient (MR1) was confused upon admission. OTH1 was unsure of the patient's mental status prior to admission.

Telephone interview with OTH2 on June 12, 2012, confirmed they did not question the amount of medications or the doses because the patient had a dementia history. When asked about the fact that the patient remained lethargic, required the rapid response the following day, and why more of the drugs were not discontinued, OTH2 stated only the Xanax was discontinued, as it was felt the lethargy initiating the rapid response was due to low blood sugar. The patient's blood sugar was 30 at the time of the rapid response. OTH2 further confirmed they became aware of the medication errors immediately prior to the patient's discharge.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on review of Medical Staff Bylaws, facility policy and procedure, facility documents, medical records (MR), and interview with staff (OTH), it was determined the facility failed to ensure the hospital protected and promoted the patient's rights by failing to order and administer medications to in a safe manner (A0144).

Findings include:

Review of review of the facility's "Medical Staff Bylaws," dated reviewed March 2, 2010, revealed "Preamble ... Community Medical Center ("CMC") is a Pennsylvania nonprofit corporation that owns and operates a licensed acute care hospital in Scranton, Pennsylvania. The Medical Staff of CMC is a single, organized, self-governing unit of CMC which has been delegated certain responsibilities, on behalf of the Board (defined below), and provides oversight of the quality of patient care, treatment,services and safety delivered by all Practitioners and others who maintain Clinical Privileges through the Medical Staff. ... The Medical Staff has overall responsibility for the quality of medical care delivered to patients and such other responsibilities, as are delegated or conferred by Pennsylvania law, The Joint Commission, Medicare, the Bylaws, the Medical Staff Rules and Regulations, Medical Staff and applicable CMC policy and procedure manuals."

Review of the facility's policy and procedure "Patient Rights and Responsibilities," dated reviewed July 2011, revealed "Policy: 1. It is the policy of Community Medical Center to ensure that the basic human rights of expression, education, nationality, ancestry or who will pay the bill. 2. All Patients will receive care, treatment and services that will safeguard their personal dignity and respect their cultural, psychosocial and spiritual values. 3. Patients have the right to: ... Care Delivery: ... Receive care in a safe setting ... Receive kind, respectful, safe quality care by skilled staff ... Receive efficient an quality care with high professional standards that are continually maintained and reviewed."

Review of the facility document "CMC (Community Medical Center) Rights and Responsibilities of Patients" pamphlet, dated revised March 2011, revealed "... The Right to a Safe Environment. ... Each patient has the right to receive care in a safe setting free from any abuse or harassment."

Cross Reference:
482.13(c)(2) Patient Rights: Care in a Safe Setting
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on review of facility policy and procedures, facility documents, review of medical records (MR) and interviews with staff (EMP), it was determined that the facility failed to order and administer medications to in a safe manner for one of 10 medical records reviewed (MR1).

Findings include:

Review of the facility's policy and procedure "Patient Rights and Responsibilities," dated reviewed July 2011, revealed "Policy: 1. It is the policy of Community Medical Center to ensure that the basic human rights of expression, education, nationality, ancestry or who will pay the bill. 2. All Patients will receive care, treatment and services that will safeguard their personal dignity and respect their cultural, psychosocial and spiritual values. 3. Patients have the right to: ... Care Delivery: ... Receive care in a safe setting ... Receive kind, respectful, safe quality care by skilled staff ... Receive efficient an quality care with high professional standards that are continually maintained and reviewed."

Review of the facility document "CMC (Community Medical Center) Rights and Responsibilities of Patients" pamphlet, dated revised March 2011, revealed "... The Right to a Safe Environment. ... Each patient has the right to receive care in a safe setting free from any abuse or harassment."

Review of MR1 revealed the patient had been admitted to the hospital from a personal care home on June 3, 2012, with symptoms of abdominal pain, nausea, vomiting, possible G.I. (gastrointestinal) bleed and bipolar disease. Continued review revealed the personal care home had sent the medication reconciliation for MR1. The personal care home also sent the medication reconciliation for another patient (PT1) at the personal care home. The physician orders revealed medications for MR1 and PT1 were ordered and administered to MR1.

Review of the nursing documentation in MR1 revealed the patient was lethargic to the point that the nursing staff held medication. When the patient became more alert, the medication was resumed. The patient again became lethargic. There was no documentation the physician orders were questioned with respect as to why the patient was receiving so many medications that affected the patient's mentation. Continued review revealed there was no discussion with the pharmacist as to why the patient was receiving so many medication affecting the patient's mentation.

Interview with OTH1 at approximately 11:30 AM on June 12, 2012, confirmed that if the patient was demented and if the patient was on the drugs prior to admission they would continue the medications. OTH1 stated it was not unusual to see this number of medications and at that doses noted above in a patient with dementia. OTH1 also confirmed the patient (MR1) was confused upon admission. OTH1 was unsure of the patient's mental status prior to admission.

Telephone interview with OTH2 on June 12, 2012, confirmed they did not question the amount of medications or the doses because the patient had a dementia history. When asked about the fact that the patient remained lethargic, required the rapid response the following day, and why more of the drugs were not discontinued, OTH2 stated only the Xanax was discontinued, as it was felt the lethargy initiating the rapid response was due to low blood sugar. The patient's blood sugar was 30 at the time of the rapid response. OTH2 further confirmed they became aware of the medication errors immediately prior to the patient's discharge.

Interview with EMP1 on June 12, 2012, at approximately 9:30 AM confirmed MR1 was on many medications affecting mentation. EMP1 confirmed the Pharmacy Override Log revealed there were several alerts that would prompt the pharmacist to question the dosage. EMP1 confirmed no action was taken to rectify the overdosage.

Interview with EMP3 on June 12, 2012, at approximately 10:30 AM confirmed there were 78 pharmacy overrides, 11 of which were classified as serious. EMP3 confirmed there was no discussion with the physician regarding the quantity of medications ordered that affected the patient's mentation.

Continued interview with EMP3 on June 12, 2012 at approximately 10:30 AM confirmed these pharmacy alerts were not clarified. EMP3 confirmed the pharmacy policy for clarification of physician orders was not followed. EMP3 further stated "It is not unusual for patients with psychiatric diagnoses to be on many medications in high doses." Further interview with EMP3 confirmed the policy for pharmacy interventions was not followed.

Cross reference:
482.12(a)(5) Medical Staff - Accountability
482.23(c)(1) Administration of Drugs
482.25 Pharmaceutical Services
482.25(a)(1) Pharmacist Responsibilities
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy and procedures, medical records (MR), and interviews with staff (EMP), the facility failed to ensure that medication reconciliation was accurate and in accordance with the approved facility policies and procedures for one of 10 medical records reviewed (MR1).

Findings include:

Review of the facility's policy "Medication Reconciliation," dated reviewed June 2012, revealed "It is the policy of Community Medical Center to develop, reconcile and communicate an accurate medication list throughout the continuum of care. ... Purpose: To ensure a consistent process for the development, communication, and reconciling patient's medications on admission and discharge. ..."

Review of MR1 revealed an admitted [DATE], from a personal care home. The medication reconciliation record revealed the following medications were ordered: Clozaril (an anti-psychotic) 25 mg. PO (orally) TID (three times a day), Clozaril 100 mg. at bedtime, Xanax (a benzodiazepine--psychoactive drug) 0.5 mg. PO at bedtime, Lithium (used to treat manic behavior) 300 mg. PO at bedtime, Namenda (an Alzheimer medication) 10 mg. PO daily, Aricept (a medication for dementia) 10 mg. PO daily, K-Dur (a potassium replacement) 20 mg. PO daily, Lasix (a diuretic) 40 mg. PO daily, glucotrol XL (used to control blood sugar) 2.5 mg. PO daily, Ambien (a sedative) 10 mg. PO daily, Seroquel(used to treat Schizophrenia and Bipolar disorders) 300 mg. PO at bedtime, Celexa (used to treat depression) 20 mg. PO at bedtime, Ventolin (a bronchodilator) 2 puffs QID (four times a day), Xanax 2 mg. PO TID, Neurontin (used to treat nerve pain), Oxycontin (a narcotic) 80 mg. PO q (every) 8 hrs., Enablex (used to treat an overactive bladder) 7.5 mg. PO daily, Voltaren (an anti-inflammatory medication) 50 mg. PO BID (two times a day), Lactaid (used to neutralize lactic acid) 2 tabs PO daily, Pepcid (used to treat heartburn and ulcers) 20 mg. PO TID, Ferrous Sulfate (an iron replacement) 325 PO daily, Tylenol (a pain reliever and also used to reduce fever) 325 mg. PO QID, PRN (as needed) for fever.

The Pepcid, Voltaren, K-Dur, Lasix and Glucotrol were discontinued.

All the other medications were continued. Further review of MR1 revealed there were two medication sheets sent from the personal care home. One medication sheet was for MR1. The other medication sheet belong to another patient (PT1) at the personal care home. Review of the medication sheets in MR1 sent by the personal care home revealed the Ambien, Seroquel, Celexa, Ventolin, Xanax 2 mg. TID, Ventolin, Neurontin and Oxycontin were ordered at the personal care home for PT1. The name of PT1 appeared at the bottom of the medication sheet sent by the personal care home.

The addition of these medications for PT1 to MR1 resulted in 47 medication errors occurring during the admission of MR1 at Community Medical Center.

Further review of MR1 revealed a Rapid response (A team called to respond quickly to failing patients in and out of the ICU before their condition worsens) was initiated on the patient to lethargy on June 4, 2012, at 12:00 noon. At that time, the Xanax 0.5 mg. TID was held due to excess sedation. Further review revealed the patient underwent an endoscopic procedure on June 5, 2012. The patient was administered 40 mg. of Diprivan (an anesthetic used to produce relaxation or sleep before or during surgery). The patient became difficult to arouse, required Narcan (an opoid reversal agent) times two, and was ultimately transferred to the Intensive Care Unit. At this time, the Celexa, Clozaril, and Xanax were discontinued. The Oxycontin was lowered to 40 mg. PO BID. The Neurontin was lowered to 300 mg. PO TID.

Interview with EMP1 confirmed the nurse performing the medication reconciliation did not notice that another patient's medication sheet was included in the transfer forms from the personal care home. The nurse who recorded the medication reconciliation was unable to be contacted at the time of the survey.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on review of facility policy, facility documents, medical records (MR) and interview with facility staff (EMP), it was determined the facility to ensure pharmaceutical services met the needs of the patient by failing to ensure established policies for clarification of ordered medications and pharmacists interventions were consistently implemented (A0492).

Findings include:

Review on June 12, 2012, of the facility's policy "Clarification and Verification of Physician's Orders," last reviewed March 12, 2012, revealed "Policy: It is the policy of the CMC (Community Medical Center) Pharmacy to verify or clarify Physician's orders that are incomplete, unreadable or otherwise unclear prior to the medication being dispensed. 1. Blanket orders such as "continue home meds", resume previous orders", "restart pre-op meds" or "discharge on current meds" are not acceptable orders, and must be clarified. 2. If there is any question regarding a medication prescribed, dose or strength (e.g. very high or very low), administration frequency, or dosage interval, a nurse or pharmacist will contact the subscriber to verify/confirm the order. Questionable orders will be verified/confirmed prior to dispensing or administering the medications. 3. Clarification of medication orders must be written as a new Physician's order prefixed by "clarification" followed by the clarified order. For Example: Clarification: Digoxin 0.125 mg. PO daily" with TORBV. 4. Medication reconciliation Forms which are incomplete or contain unclear or otherwise questionable information must be clarified with the physician."

Review on June 12, 2012, of the facility's policy "Pharmacist Intervention Guidelines," last reviewed March 2012, revealed "It is the policy of the CMC Pharmacy to intervene with the Physician's Orders that require clarification or otherwise are potentially problematic. Examples of orders which might require intervention include, but are not limited to, the following: 1. Confirm Order: Any order which is unusual or requires certifying any parameter of a drug order including name, strength, route,dose, or timing as it relates to a dosing parameter. Nurse, physician, or other caregiver may be contacted in this effort. ... 2. Duplicate therapy: Any order that is for the same or similar modality or at nearly the same parameters without a corresponding adjustment or discontinuance of the prior entity or modality."

Cross reference:
482.25(a)(1) Pharmacist Responsibilities
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on review of pharmacy policies, pharmacy documents, medical records (MR), and interview with facility staff (EMP), it was determined the chief pharmacist failed to ensure established policies for clarification of ordered medications and pharmacists interventions were consistently implemented for one of 10 medical records reviewed (MR1).

Findings include:

Review on June 12, 2012, of the facility's policy "Clarification and Verification of Physician's Orders," last reviewed March 12, 2012, revealed "Policy: It is the policy of the CMC (Community Medical Center) Pharmacy to verify or clarify Physician's orders that are incomplete, unreadable or otherwise unclear prior to the medication being dispensed. 1. Blanket orders such as "continue home meds", resume previous orders", "restart pre-op meds" or "discharge on current meds" are not acceptable orders, and must be clarified. 2. If there is any question regarding a medication prescribed, dose or strength (e.g. very high or very low), administration frequency, or dosage interval, a nurse or pharmacist will contact the subscriber to verify/confirm the order. Questionable orders will be verified/confirmed prior to dispensing or administering the medications. 3. Clarification of medication orders must be written as a new Physician's order prefixed by "clarification" followed by the clarified order. For Example: Clarification: Digoxin 0.125 mg. PO daily" with TORBV. 4. Medication reconciliation Forms which are incomplete or contain unclear or otherwise questionable information must be clarified with the physician."

Review on June 12, 2012, of the facility's policy "Pharmacist Intervention Guidelines," last reviewed March 2012, revealed "It is the policy of the CMC Pharmacy to intervene with the Physician's Orders that require clarification or otherwise are potentially problematic. Examples of orders which might require intervention include, but are not limited to, the following: 1. Confirm Order: Any order which is unusual or requires certifying any parameter of a drug order including name, strength, route,dose, or timing as it relates to a dosing parameter. Nurse, physician, or other caregiver may be contacted in this effort. ... 2. Duplicate therapy: Any order that is for the same or similar modality or at nearly the same parameters without a corresponding adjustment or discontinuance of the prior entity or modality."

Review of the medication reconciliation sheet revealed question marks and notations next to the Seroquel an "XR???", and a "yes" and "no" noted by the Xanax and Celexa.

Interview with EMP 3 on June 12, 2012 at approximately 10:30 AM stated it looked like there were some questions regarding these drugs, Seroquel, Xanax and Celexa. There were no clarifications noted on the physician orders sheet.

Review of the pharmacy override log for MR1 revealed a total of 78 overrides for MR1 from June 3, 2012, thru June 7, 2012. The overrides were generated by the computer program and were regarding duplication of drugs, dose alerts for medications nearing or exceeding maximum dose, warnings about caution when using certain drugs in the geriatric population, and possible additive side effects when using drugs in combination. There was no indication or documentation these alerts were addressed by the pharmacy staff. Of the 78 overrides, in MR1, 11 warned of a possible severe reaction, for example "Drug interaction(s) - Clozapine 100 mg. tablet Adverse reaction of Alprazolam 1 mg Tablet Severity: Severe Interaction" (there was a possible drug interaction when administering Clozapine 100 mg. tablet and Alprazolam 1 mg. tablet. The severity was a severe interaction).

Interview with EMP 3 on June 12, 2012, at approximately 10:30 AM confirmed the alerts for MR1 were not clarified. EMP3 confirmed the facility policy for clarification of physician orders was not followed. EMP3 further stated "It is not unusual for patients with psychiatric diagnoses to be on many medications in high doses." Further interview with EMP3 confirmed the policy for Pharmacy interventions was not followed.