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Based on clinical record review and staff interview, the hospital failed to provide an accurate medical record for one out of seven reviewed clinical records (Patient 301) as the recapped order for Neutra-Phos failed to show a two day duration (held internally in the system) as originally ordered two days prior to the recap, that the physician could see when he issued a telephone order for the recapped order. As written, the order would have been good for 30 days unless the pharmacist called the physician to clarify the duration of the order with the physician (which was possible as the electronic version of the order did contain a two day duration with the order which the verifying pharmacist could see via the pharmacy computer system).

Findings:

On 4/25/11 a review of Policy and Procedure PCM VI.A.8 entitled AUTOMATIC STOP ORDERS (Approved 11/17/10; Revised: 3/11) indicated that it stipulated a number of classes of medications with automatic stop dates less than 30 days. These were controlled substances (drugs subject to abuse and hence under tight control as stipulated by law), antibiotics, anticoagulants (blood thinners), and ketorolac (used to treat pain). Those medications not so included among these designated medications would automatically stop after 30 days if not continued by the physician. Neutra-Phos was one of the latter medications as it was not included in those medications specifically designated by the hospital policy to have a shorter automatic stop date. Neutra-Phos is used to replace phosphorous lost secondary to excessive phosphorous elimination by the kidney or due to poor adsorption in the diet. It comes in 1.25 gm packets that contain the medication in powder form which can be dissolved in water so a patient can drink the resulting solution.

On 4/26/11 a review of Patient 301's clinical record indicated that on 4/14/11 a physician ordered that Patient 301 receive Neutra-Phos two packets three times daily for two days. The patient then changed level of care on 4/16/11 (went to a different area of the hospital) and a "Transfer/Discharge Medication Review & Order Sheet" (TDMROS: included each drug order the patient had been on and which provided boxes for each order which a physician could check to indicate if the drug was to be continued or discontinued). In this case the TDMROS was taken as a telephone order from a physician by a nurse. The Neutra-Phos order was recapitulated and the continue box was checked by the nurse for the physician. There was no duration (such as "for two days") that appeared on the written recapped medication order so at that point, the order would be considered to be good for 30 days. The order subsequently dropped off the record the next day.

During an interview of Administrative Pharmacist M at 10:06 a.m. on that date, he stated that a stop date was built into the order but it did not print out on the TDMROS. He stated that it was a "systems issue" and that the trouble with this particular form is it did not indicate the duration of the order. He stated that a pharmacist would have been able to see the two day stop period entered into the electronic profile for this order as was done when the order was originally entered. He checked the electronic clinical record for Patient 301 and could find no evidence that the pharmacist had called the physician to see if that physician had wanted to continue the order as a two day order as originally ordered on 4/14/11 or to go for 30 days as indicated by the physician on the telephone order.

Based on clinical record review, document review, and staff interview, the hospital failed to ensure that pharmaceutical services met the patient needs, and failed to develop a policy and procedures that ensured patients would be free of medication errors as evidenced by:

1. The failure of the hospital to develop a system that ensured the safe use of fentanyl patches (used to control chronic pain), which have a boxed warning. A boxed warning is the most serious warning required by the Food and Drug Administration (FDA) and involves certain contraindications or serious warnings, that may lead to death or serious injury. The FDA is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States. As a result a fentanyl patch was ordered for a patient (Patient 300) who did not meet the opioid tolerance requirements stipulated in the FDA approved product labeling (FDA required information regarding indications, precautions, warnings, and other information provided as a package insert with a given medication) and no evidence was provided that the pharmacist who entered the order into Patient 300's computerized medication profile questioned the order. The patch was not available but had it been in stock, no evidence was provided that it would not have been placed on Patient 300 as ordered which would have exposed this patient to the potential development of respiratory decompensation (significant decrease in the rate of his breathing). This was an issue during the October 2010 survey. Furthermore, the hospital policy regarding fentanyl patches, as written, would not prevent the off-label use (contrary to the product labeling) of the fentanyl patch in the absence of special procedures to ensure the safe use of the patch when ordered off-label (see A500, #1 and #2).

2. The failure of the hospital to ensure that hospital approved protocols were followed for vancomycin (an antibiotic) dosing or approved and put in place for pharmacist dose adjustment and monitoring of aminoglycoside therapy (a class of antibiotics) as required by state law (California Business and Professions Code 4052.1). Furthermore the hospital failed to ensure that the vancomycin protocol defined the pharmacist training to do this as required by state law (California Business and Professions Code 4052.1). This could expose patients to the risk of improperly calculated doses and inadequate monitoring (see A500, #3).

3. The failure of the hospital to implement the hospital policy regding the "Home Medications Review and order Sheet" to ensure that was reviewed by the physician for inclusion or exclusion of the listed medications from the home medication regimen into the hospital medication regimen for one out of five patients (Patient 300) whose records the surveyor checked for inclusion of this record and the failure to ensure the pharmacist followed-up with the physician following this failure to review this document as stipulated in the same policy. This was an issue during the October 2010 survey. This could have resulted in an adverse outcome for this patient or any patient whose list was not reviewed and who otherwise would not receive needed medications (see A500, # 4).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision for safe and effective use of drugs to meet the needs of the hospital patients and to minimize drug errors and adverse consequences.

Based on observations made in nursing care areas and the pharmacy, clinical record review, document review, and staff interview, the hospital failed to ensure that drugs were distributed and controlled according to standards of practice, consistent with state law as evidenced by:

1. The failure of the hospital to develop a system that ensured the safe use of fentanyl patches (used to control chronic pain), which have a boxed warning. A boxed warning is the most serious warning required by the Food and Drug Administration (FDA) and involves certain contraindications or serious warnings, that may lead to death or serious injury. The FDA is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States. As a result a fentanyl patch was ordered for a patient (Patient 300) who did not meet the opioid tolerance requirements stipulated in the FDA approved product labeling (FDA required information regarding indications, precautions, warnings, and other information provided as a package insert with a given medication) and no evidence was provided that the pharmacist who entered the order into Patient 300's computerized medication profile questioned the order. The patch was not available but had it been in stock, no evidence was provided that it would not have been placed on Patient 300 as ordered which would have exposed this patient to the potential development of respiratory decompensation (significant decrease in the rate of his breathing). This was an issue during the October 2010 survey. Furthermore, the hospital policy regarding fentanyl patches, as written, would not prevent the off-label use (contrary to the product labeling) of the fentanyl patch in the absence of special procedures to ensure the safe use of the patch when ordered off-label (see #1 and #2).

2. The failure of the hospital to ensure that hospital approved protocols were followed for the adjustment and monitoring of vancomycin (an antibiotic) therapy via trough levels (versus use of random levels as noted clinical record review) and the failure of the hospital to ensure that an approved aminoglycoside (a class of antibiotics) dosing policy was put into place for pharmacist dose adjustment and monitoring of aminoglycoside therapy as required by state law (California Business and Professions Code 4052.1) when review of five patient records (Patient 301 through 305) indicated pharmacists were adjusting vancomycin and aminoglycoside doses. The pharmacists were using random vancomycin levels to adjust doses, not trough levels as stipulated by the hospital policy. Furthermore the hospital failed to ensure that the vancomycin protocol defined the pharmacist training to do this as required by state law (California Business and Professions Code 4052.1). This could expose patients to the risk of improperly calculated doses and inadequate monitoring (see #3).

3. The failure of the hospital to develop a system to ensure that the "Home Medications Review and order Sheet" was reviewed by the physician for inclusion or exclusion of the listed medications from the hospital medication regimen of one out of five patients (Patient 300) whose records the surveyor checked for inclusion of this record and the failure to ensure the pharmacist followed-up with the physician following this failure to review this document. This could have resulted in an adverse outcome for this patient or any patient whose list was not reviewed and who otherwise would not receive needed medications (see # 4).

4. The failure to ensure that the posted content list on two out of two Malignant Hyperthermia (MH) Carts matched the contents as established in the hospital policy and procedure for MH. MH is a rare but potentially lethal side effect of medications used in anesthesiology and is considered to be a medical emergency. MH Carts contain medications and equipment used to treat MH (see #5).

5. The failure of the hospital to store neuromuscular blockers (used to relax skeletal muscle to facilitate surgical procedures) and insulin (used to control high blood sugar levels in diabetics) in the Surgery Department refrigerator according to manufacturer's specifications (36 to 46 deg F): the refrigerator temperature registered 32 deg F (freezing: see #6).

6. The failure to ensure that policies were kept up to date in that Policy PHM IV.B.19 entitled INTERCHANGE PROGRAM (AND SHORTAGES) listed droperidol as a possible drug to use in therapeutic interchange when, in fact, it was no longer on the formulary during the survey (see #7).

Findings:

1. The fentanyl transdermal system (brand name is Duragesic) also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that it has an associated risk of fatal overdose due to respiratory depression. It documents that the fentanyl patch is indicated for the management of persistent moderate to severe chronic pain that requires continuous around-the-clock opioid (narcotic pain relievers derived from or having the pain relieving action of opium) administration for an extended period of time and that cannot be managed by other pain medications such as non-steroidal antiinflammatory medications which include ibuprofen (Motrin), combinations of acetaminophen and opiates such as Vicodin and Percocet, or pure opiates such as morphine. It documents that use of this patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression (decrease in rate of breathing) can occur. It documents that it should only be used in patients who are opioid-tolerant which is defined in the boxed warning as those patients who have taken at least 60 mg of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opiate medications used to treat pain) daily for a week or longer or an equianalgesic dose of another opiate medication. It documents that a patient who has taken the equivalent of 60 mg of oral morphine for seven days can use a 25 mcg/hr fentanyl patch. There is no indication in the product labeling for initiation of therapy with a 12 mcg patch (which is an available dosage form to bridge dosage increases between the 25, 50, 75, and 100 mcg/hr patches based on supplemental immediate release narcotic use).

On 4/25/11 a review of the current policy and procedure (no policy number) entitled FENTANYL PATCH USE (Approved 10/21/10; Revised 11/22/10) indicated under "Policy: Compliance - Key Elements" that: "Due to the Food and Drug Administration ...black box warning, this policy and procedure restricts prescribing to opioid tolerant patients ...". The Food and Drug Administration (FDA) is the institution that regulates the approval, labeling, and all regulatory issues regarding medications in the United States. Under "Procedure F" it provided a definition of opioid tolerance that was identical to that found in the product labeling for the fentanyl patch. It documented under this section that "Fentanyl patches are contraindicated in: Patient (sic) who are not opioid tolerant". The policy documented that: "the efficacy of the fentanyl patch 12 mcg/hr as an initiating dose has not been determined" and the policy documented this verbiage came from the product labeling for this medication.

On 4/28/11 at 11:25 a.m. a review of Patient 300's clinical record indicated that the patient was admitted on 3/23/11 at 3:47 p.m. The clinical record contained a "Transfer/Discharge Medication Review" that included a list of the medications that patient took at home. A review of this sheet indicated it did not document that Patient 300 took opioid pain control medications at home.

On 4/1/11 at 9 a.m. a physician ordered Vicodin (each tablet contains 5 mg hydrocodone: a narcotic pain reliever and 500 mg acetaminophen: the active ingredient of Tylenol) one tablet as needed every four hours for mild pain and two tablets every for hours as needed for moderate pain. On 4/9/11 (no time indicated but the earliest nursing notation on this order was timed at 9:10 p.m.) a physician ordered that staff place a 12 mcg/hr fentanyl patch (delivers fentanyl at a constant rate of 12 mcg/hr) on Patient 300 but a review of the medication administration records (MARs: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that no patch had been placed on Patient 300.

A further review of the MARs indicated that Patient 300 received the following amounts of hydrocodone (with the oral morphine equivalent in parentheses) each day for the seven days prior to the date and time of the pharmacist entry of the fentanyl patch order into the computer:

4/3/11: 20 mg (20 mg)

4/4/11: 40 mg (40 mg)

4/5/11: 30 mg (30 mg)

4/6/11: 30 mg (30 mg)

4/7/11: 20 mg (20 mg)

4/8/11: 25mg (25 mg)

4/9/11: 30 mg (30 mg)

Patient 300 received an average of 28 mg/day of oral morphine equivalents during this period which was less than half the amount of oral morphine to be considered opiate tolerant.

On 4/28/11 at 11:45 a.m. during an interview of Administrative Pharmacist M he checked Patient 300's computerized medication profile in the pharmacy and then stated that Pharmacist N came into the pharmacy on 4/9/11 at 11:19 p.m. and entered the order for the fentanyl patch into Patient 300's profile (the last dose of Vicodin administered to Patient 300 on 4/9/11 was at 10:15 p.m. per the MAR for that date). Pharmacist N subsequently canceled this order (two days later) on 4/11/10 per Administrative Pharmacist M. Administrative Pharmacist M then showed the surveyor the narcotic records for the pharmacy, a review of which indicated that 12 mcg/hr patches were not available in the pharmacy on 4/9/11 or 4/10/11. Administrative Pharmacist M stated that staff pharmacists could leave notes regarding their clinical activities in the "Patient Notes" section of the computerized profile. A review of the "Patient Notes" section of Patient 300's computerized profile at that time indicated it contained no evidence that Pharmacist N contacted the physician and told him that Patient 300 was not opiate tolerant per the product labeling as well as the hospital policy and procedure. No evidence was provided that Pharmacist N discussed with the prescribing physician that there was no indication for initiating therapy with a 12 mcg/hr fentanyl patch in someone who did not meet the definition of opiate tolerance.

2. On 4/25/11 a review of the current policy and procedure (no policy number) entitled FENTANYL PATCH USE (Approved: 10/21/10; Revised 11/22/10) indicated the following issues:

a. It stipulated under "Pharmacist Responsibility" that: "The pharmacist or the nurse shall contact the physician if the patient does not meet criteria as an opioid-tolerant patient or other conditions exist in which the fentanyl patch is contraindicated". Under "RN Responsibility" it stipulated: "The nurse shall contact the physician for concerns about possible contraindications related to the patient's condition as a result of the Black Box Warning. It is ultimately the physician's responsibility to decide if the contraindication requires discontinuing the drug". Neither section provided any direction to staff as to what course to take if they disagreed with the physician's assessment in that they were concerned the patient might experience respiratory decompensation (significant decrease in the patient's ability to maintain spontaneous breathing) if the patch were placed on the patient as ordered.

b. Under "RN Responsibility" it stipulated that nurses"...perform their required monitoring" but it did not specify exactly what "required monitoring" entailed.

c. It provided for application of a 12 mcg/hr fentanyl patch for patients who had received less than 45 mg of oral morphine per day and/or who have been receiving opioids (total daily dose not specified) for less than 7 days even though there was no provision for this in the fentanyl patch product labeling. It stipulated that "Patients in this category require increased monitoring for a minimum of 72 hours" yet the nature of this "increased monitoring" was not specified and hence would be left up to the individual nurse rather than being developed under the considered judgment of the physician, pharmacist, nursing and administrative members of the Pharmacy and Therapeutics Committee (the committee responsible for the development of policies and procedures regarding medication issues and other issues regarding the hospital pharmaceutical services).

d. It exempted "Hospitalized patients initiated on the end of life COMFORT CARE PATHWAY ...from this policy and procedure."

On 4/29/11 at 12:11 during an interview of Administrative Pharmacist M in the pharmacy he stated that using oral doses of opioids equivalent to 45 mg of morphine a day to justify placement of a fentanyl patch would represent off-label use. He stated that he was not privy to the discussion regarding end-of-life use of the patch and did not know the justification for inclusion of this exception in the hospital fentanyl patch policy. He agreed that the policy did not provide direction to staff as to what the expectation would be if they disagreed with the physician regarding the indication for placement of the fentanyl patch. Administrative Pharmacist M agreed that the policy did not describe what monitoring precautions staff was to take to protect a patient from respiratory decompensation should a patient who did not meet the product labeling guidelines regarding opioid tolerance have a patch placed on him.

3. California Business and Professions Code 4052.1 entitled PERMITTED PHARMACIST PROCEDURES IN LICENSED HEALTH CARE FACILITIES stipulates that a pharmacist may order "...drug therapy-related laboratory tests" and initiate or adjust "...the drug regimen of a patient pursuant to an order of authorization made by the patient's prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility". It also stipulates that "Prior to performing any procedure authorized by this section, a pharmacist shall have received appropriate training as prescribed in the policies and procedures of the licensed health care facility".

The American Society of Health System Pharmacists is a nationally recognized organization that sets standards of practice for hospital pharmacies. It published an AHSP Therapeutic Consensus Statement in 2009 entitled THERAPEUTIC MONITORING OF VANCOMYCIN IN ADULT PATIENTS: A CONSENSUS REVIEW OF THE AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS, THE INFECTIOUS DISEASES SOCIETY OF AMERICA, AND THE SOCIETY OF INFECTIOUS DISEASES PHARMACISTS. In this statement it documented that "Trough serum vancomycin concentrations are the most accurate and practical method for monitoring efficacy. It documented that troughs should always be maintained above 10 mg/L and that in complicated infections documented as bacteremia (blood infection), endocarditis, osteomyelitis, meningitis (infection of the membranes surrounding the brain and spinal cord), and hospital acquired pneumonia caused by Staphylococcus aureus, the recommended levels were 15-20 mcg/L. Trough levels are those levels drawn just prior to the next scheduled dose of a medication. Random levels are levels that are drawn anywhere between the administration of a dose and the next scheduled dose of a medication.

On 4/25/11 at 9:30 a.m. the surveyor requested copies of all hospital approved drug dosing protocols. Later that morning Administrator SS provided Policy and Procedure PHM IV.A.8 entitled ADULT VANCOMYCIN DOSING/MONITORING PROTOCOL (Written 8/2005, Revised 12/2009) a review of which indicated:

"A physician who requests vancomycin dosing by the Pharmacy will write an order stating this".

"If the prescribing physician does not order a target trough, the target trough shall be greater than 20 mg/L (milligrams/liter) for presumed or documented MRSA (methicillin resistant Staphylococcus aureus: a bacteria resistant to the antibiotic methicillin and hence considered resistant to other antibiotics similar to methicillin) pneumonia, MRSA SBE (subacute bacterial endocarditis: an infection in the heart), or MRSA osteomyelitis (a bone infection); greater than 15 mg/L for other infections".

"The appropriateness of the dose should be assessed by measuring a serum trough concentration prior to the third dose or thereafter".

"Pharmacists will document their activities in the Progress Notes (area of the chart where the physician writes his/her notes) such that the ordering physician can maintain oversight at all times".

On 4/26/11 at 12:57 p.m. during an interview of Administrative Pharmacist M in the pharmacy, he stated that, except for the dosing of warfarin (a blood thinner) all dose adjustments done in this hospital for vancomycin and aminoglycosides were done by consulting with the physician for a given dosage change followed by the writing of a verbal order in a given patient's clinical record. He stated he did not follow the vancomycin dosing policy. Verbal and telephone orders are orders that are taken verbally either in the presence of the physician or over the telephone and are then reduced to writing by the person taking the order which includes the prescriber's name and licensure category (such as M.D.) and the signature and licensure category (such as RPh) of the person taking the verbal or telephone order.

On 4/26/11 a review of Patient 301's clinical record indicated that on 4/2/11 at 5:30 a.m. a physician ordered "vancomycin per pharmacy". On 4/2/11 at 12 noon Pharmacist O ordered a random vancomycin level (not a trough) for the morning labs to drawn the following Monday. It was not written as a verbal or as a telephone order. On 4/6/11 at 12:25 p.m. Student Pharmacist Q under the documented supervision of Pharmacist P wrote an order for a random vancomycin level to be drawn the following morning. Later that day at 6:43 p.m. Pharmacist P wrote a telephone order for daily vancomycin random level starting 4/7/11. There were no pharmacist notes in the clinical record as stipulated per provided Policy and Procedure PHM IV.A.8.

On 4/27/11 a review of Patient 302's clinical record indicated that on 2/11 (no time indicated) a physician ordered "Vancomycin per pharmacy". On 2/11/11 at 7 p.m. Pharmacist R wrote an order for a random vancomycin level with the morning labs on 2/12/11 and 2/13/11. It was not written as a telephone order. On 2/13/11 at 9:30 a.m. Pharmacist R wrote a telephone order for a random vancomycin level to be drawn the following morning on 2/14/11 but on 2/14/11 at 9:30 a.m. Pharmacist P wrote a telephone order to hold the vancomycin dose and to obtain a random vancomycin level in the evening between 7 p.m. and 7:30 p.m. On 2/16/11 at 12 noon Pharmacist P wrote a telephone order for a random vancomycin level to be drawn that evening between 7 p.m. and 7:30 p.m.

On 4/27/11 a review of Patient 303's clinical record indicated that on 4/10/11 at 1:10 p.m. Pharmacist P took a verbal order from a physician for vancomycin 2 grams one time "now" followed by a vancomycin regimen that was to start 4/11/11. There was no request for the pharmacist to dose the vancomycin by the physician. Included in this order set was an order for random vancomycin levels daily for 2 days. On 4/12/11 at 9:31 a.m. Student Pharmacist Q under the documented supervision of Pharmacist P wrote an order for a random vancomycin level at 7 p.m. that evening. It was written as a telephone order from a physician. On 4/20/11 at 8:37 a.m. Student Pharmacist Q under the documented supervision of Pharmacist S wrote a telephone order for a random vancomycin level to be drawn during the morning labs on 4/22/11.

On 4/27/11 a review of Patient 304's clinical record indicated that on 4/22/11 at 11:34 p.m. a physician's assistant wrote an order for gentamicin (an aminoglycoside antibiotic) 80 mg IVPB (intravenously via small IV bags called "piggy backs" as they are often "piggybacked" on to a main IV connected to a large volume IV solution) every 8 hours with "peak & trough per pharmacy". On 4/23/11 at 8:40 a.m. Pharmacist MM wrote an order to continue the gentamicin 80 mg IVPB every 8 hours and to obtain a trough gentamicin level that evening. It was written "For Dr. (Physician NN)" and signed by Pharmacist MM. It was not written as a telephone order.

On 4/12/11 a review of Patient 305's clinical record indicated that on 3/10/11 Pharmacist OO wrote an order "for Dr (Physician PP)" that read "Gentamicin dosing per pharmacy ...(1) Hold gentamicin doses for today (2) Cont. daily gentamicin levels w/ AM labs Pharmacy to follow". On 3/8/11 at 7:10 p.m. Pharmacist MM wrote: "Gentamicin per Pharmacy. (1) Gentamicin 360 mg IVC once today - already given. (2) Daily gentamicin levels with AM blood draw". It was signed "For Dr (Physician PP)" followed by Pharmacist MM's signature. Neither order was a telephone order.

On 4/26/11 at 3:08 p.m. during an interview of Physician QQ he stated that he had ordered initial doses of vancomycin or gentamicin and then ordered that the pharmacists follow these drugs per the pharmacy protocols for these drugs. He stated the pharmacist would write the recommended dose and he would cosign it. He stated that having the pharmacist call him each time would be "onerous". He said that if the pharmacist called him each time the pharmacist wrote an order for these drugs (after he had requested them per protocol) that the hospital might as well not have a protocol. He stated that if he had questions about a given order he would call the pharmacist. He stated that the pharmacists did not call him each time they wrote an order although sometimes they did call him.

On 4/28/11 at 12:47 p.m. during an interview of Physician NN he stated that he was aware of hospital protocols where the pharmacists adjusted the doses of medications. He said that vancomycin and tobramycin (an aminoglycoside antibiotic similar to gentamicin) were the drugs he had the pharmacists dose. He stated that he would write a starting dose and then have the pharmacist adjust the dose. He stated that the pharmacists usually just wrote the orders without calling him but at times they did call him with a concern. He stated that his expectation was that the pharmacist would adjust the dose without calling him. He said he did not believe there was a hospital protocol to do this. He said: "They are PhDs in pharmacokinetics. That is what they do. That is their job". Most pharmacists have a Doctor of Pharmacy degree or Pharm.D. Pharmacokinetics is a field of study involving how fast a drug is adsorbed, distributed in the body, and eliminated from the body. For certain drugs such as vancomycin and the aminoglycosides it is possible to calculate doses using pharmacokinetic parameters.

On 4/28/11 at 1:10 p.m. during an interview of Physician RR, he stated he was the Chairperson of the Pharmacy and Therapeutics (P&T) Committee (the committee responsible for the development of policies and procedures regarding medication issues and other issues regarding the hospital pharmaceutical services). He stated that he was aware of pharmacy protocols for vancomycin and aminoglycosides. He stated that the prescribing physician would write an order a given drug "per pharmacy" or "per protocol". He said he would not expect the pharmacist to call the physician for each order written. He said the protocols were independent of a telephone order and that he believed that the protocols had been approved by the P&T Committee. The surveyor showed Physician RR the vancomycin protocol. He stated that if the policy had been revised he would have seen it. He was with the P&T Committee in December 2009 (the documented revision date printed on the vancomycin protocol). He stated that the physician staff would expect the pharmacists to follow this protocol.

On 4/28/11 at 1:24 p.m. during in interview of Administrator SS she stated she had not found any hospital approved protocol for aminoglycosides.

On 4/28/11 at 4:25 p.m. during an interview of Pharmacist S, he stated that Student Pharmacist Q wrote the 4/20/11 order in Patient 303's clinical record. He stated that he double checked the students work, labs for the patient, and other pertinent data on the pharmacy monitoring sheets when a student does this work before the order is written. He stated that he did not call the prescribing physician regarding vancomycin orders written per physician requested protocols. The surveyor asked him how random vancomycin levels were used to adjust doses. He stated one would estimate where the level would be before the next dose. He said he was not aware of anything in the (pharmaceutical or medical) literature that supported the use of a random level for dosing vancomycin. He stated that Administrative Pharmacist M taught him to use random levels. He stated he was not aware of the AHSP Therapeutic Consensus Statement regarding vancomycin. He stated he did not document his activities in the Progress Notes in a patient's clinical record as stipulated in Policy PHM IV.A.8.

Pharmacist S stated he would dose gentamicin and tobramycin if the physician ordered it per protocol. He stated he used an up-to-date program in MicroMedix (a well know pharmacological data base program) and that he did this on his own. He said he was not aware of a hospital program in the hospital that permitted this practice. He stated he did not call the doctor before writing an order if ordered "per pharmacy". He stated that if one does not call a doctor, a written order would not be a "telephone order".

On 4/28/11 at 5:04 p.m. during an interview of Pharmacist MM he stated that he had seen physician orders for vancomycin, gentamicin, and tobramycin "per pharmacy". If vancomycin was ordered per protocol, he would review the patient's clinical record and he might call the physician for the diagnosis. He stated he would aim for levels of 10 to 15 mg/L or 15 to 20 mg/L based on the diagnosis. He stated he would use the higher range for osteomyelitis, pneumonia, or sepsis and the lower range for skin infections. He stated that he would use random levels if a patient was in kidney failure. He stated if the patient had good kidney function he wrote for a trough level before the fourth dose. He stated that in the past the pharmacy mostly did random levels but were doing more troughs at the present time. He stated he had not seen Policy IV.A.8. He stated he did not document his activities in the Progress Notes (as stipulated by this policy).

He stated that he was not aware of a pharmacy protocol for dosing gentamicin. He stated he used the Infectious Diseases Society of America (IDSA) guidelines to dose aminoglycoside antibiotics (such as gentamicin and tobramycin). He stated the guidelines are at IDSA.org to determine the drug level target. He stated he also used a hospital program called Up-to-Date. He said he used MicroMedix (a drug information and drug data base program) for the actual dosing guidelines. He stated he used Global RPh (an Internet Database program) to estimate the trough. He said he used multiple resources to arrive at a dose for a patient. He said there were no written guidelines for him to follow. He identified the 3/8/11 order written at 7:10 p.m. in Patient 305's clinical record as his order and stated that he did not call Physician PP about that order.

On 4/29/11 at1:42 p.m. during an interview of Administrative Pharmacist M, he stated he had not taken the use of random levels to the P&T Committee for revision of the policy. Therefore the pharmacy was not using an approved process (when using random levels). He stated that the pharmacy was not dosing vancomycin per the hospital policy. He stated pharmacist did not document their activities in a patient's clinical record. He said he did not feel they had permission to do this despite the fact it was stipulated in Policy IV.A.8.

Administrative Pharmacist M also said that there was no protocol for pharmacists to dose aminoglycoside antibiotics. He stated the hospital needed to develop such a protocol because, in his opinion, it would be an expectation of the physicians.

4. On 4/29/11 a review of Policy and Procedure PCM IV.B.2 entitled MEDICATION RECONCILIATION (Written 10/2005, Revised 1/2007) indicated the hospital recognized that: "Medication reconciliation is part of patient care across the continuum of care". It defined "reconciliation" as: "the process of comparing what the patient ...is taking at the time of admission (to the hospital) ...with what the organization is providing to avoid errors of transcription, omission, duplication of therapy, drug-drug and drug-disease interactions, etc". The procedures stipulated it was the nursing staff responsibility to obtain the home medication information and enter it onto a "Home Medications Review and Order Sheet", print it out, and place it into the patient clinical record for physician review. The procedures stipulated it was the physician's responsibility to review this document either in the clinical record or on-line in the hospital IT system. The physician could then check of continue or stop prompts on this record to indicate to staff which home medications were to be continued and which were to be discontinued during the hospitalization. Alternatively, if using the on-line form the physician would write admission orders in the clinical record without using the form. The procedures stipulated it was the pharmacist responsibility to review the "Home Medications Review and Order Sheet" and "... to compare the home medications the patient is taking at the time of admission to those the organization is providing to avoid errors of transcription, omission, duplication of therapy, drug-drug and drug-disease interactions, etc" and if necessary "...the Pharmacist will follow hospital procedure for clarifying orders with the ordering physician".

On 4/28/11 a review of Patient 300's clinical record indicated that no "Home Medications Review and Order Sheet" was available in the clinical record. However, a staff member had filled out an "M2: Transfer/Discharge Medication Review and Order Sheet"as a telephone order on 3/23/11 at 1p.m.. This sheet indicated that Patient 300 took the following medications at home:

Amlodipine 5 mg one tablet daily
Aspirin 325 mg one tablet daily
Lisinopril (no strength, no dosage, and no frequency of administration indicated)
Metformin 1000 mg twice daily
Simvastatin 40 mg daily.

Amlodipine is used to treat high blood pressure. Daily aspirin doses can be used to prevent clotting disorders. Lisinopril is used to treat high blood pressure. Metformin is used to lower high blood sugar levels in diabetic patients. Simvastatin is used to treat high cholesterol levels.

The staff member who took the telephone order had not checked the "start" and "stop" boxes on the "Home Medications Review and Order Sheet".

The physician did not include amlodipine, lisinopril, or metformin among his admission orders written on 3/23/11 (the date of Patient 300's admission to the hospital).

On 4/29/11 at 11:49 a.m. during a review of Patient 300's computerized medication profile with Pharmacist S in the pharmacy, Pharmacist S could provide no evidence that a pharmacist contacted the prescribing physician, as required by Policy and Procedure PCM IV.B.2 to see if the amlodipine, lisinopril, and metformin had been intentionally discontinued or had been missed (omitted) by the admitting physician.

5. On 4/28/11 at 3:42 p.m. a review of Policy and Procedure SUM IV.A.9 entitled MALIGNANT HYPERTHERMIA (Accepted: 11/18/10; Revised: 4/14/11) indicated that it documented that the hospital MH Cart was to have a minimum of 3000 ml of refrigerated IV saline (0.9% sodium chloride) available for use to treat an MH case by IV infusion.

On 4/25/11 at 3:47 p.m. an inspection of the MH Cart (contains equipment and supplies used to treat this condition) in the Surgery Department indicated staff had posted a con

Based on inspection of two Malignant Hyperthermia (MH: a rare but potentially lethal side effect of medications used in anesthesiology) Carts (one in the Surgery Department and one in the Pavilion Outpatient Surgery Department) and four warmers in the Surgery Department, the hospital failed to ensure that mislabeled or unusable medications were available for patient use as evidenced by:

1. The failure to ensure that the contents of one out of two Malignant Hyperthermia (MH: a rare but potentially lethal side effect of medications used in anesthesiology) Carts matched the posted content list which resulted in the contents of the cart being mislabeled.

2. The failure to ensure expiration dates posted on the outside of the MH Cart in the Surgery Department for four out of eight medications stored in the cart (or refrigerator as required for the insulin) accurately reflected the manufacturer's expiration date printed on the labels of the medication containers contained in the cart which resulted in these medications being mislabeled.

3. The failure to ensure that two irrigation solutions stored in two out of four warmers in the Surgery Department were removed from the warmer after they had passed the date established by the manufacture at which they could be stored at the elevated temperatures found in the warmers.

4. The failure to ensure that all solutions stored in the Surgery Department warmers were dated as per hospital procedure so staff could remove them from use after they had passed the date at which the manufacturer had documented they could be stored at the elevated temperatures found in the warmers.

5. The failure to list heparin stored in Drawer 4 in four out of twenty Crash Carts (contains equipment and medications used to treat heart and lung emergencies) with a concentration and volume size of the heparin container on the external Crash Cart content list so that staff would always know what type of heparin vial and what concentration to place and/or find in the crash carts.

Findings:

1. On 4/25/11 at 3:47 p.m. an inspection of the MH Cart (contains equipment and supplies used to treat this condition) in the Surgery Department indicated it contained three 5 ml pre-filled syringes (PFS) of lidocaine 2% (used to treat dangerous irregular heart beats) and five 50 ml PFS of 8.4% sodium bicarbonate (used to decrease the acidity of a patient's blood during a medical emergency). The posted content list documented it contained three 5 ml PFS of lidocaine 1% (not 2%) and three 500 ml (not 50 ml) PFS of sodium bicarbonate. The content list serves as part of the labeling of the contents of the MH Cart. If it does not accurately reflect the contents, then the medications inside the cart are considered to be mislabeled.

2. On 4/25/11 at 3:47 p.m. an inspection of the MH Cart in the Surgery Department indicated that it contained the following medications with the following expiration dates on the manufacturer's packaging:

a. Five 50 ml PFS of 8.4% sodium bicarbonate all of which were to expire 5/1/12.

b. Four 4 ml vials of furosemide 10 mg/ml for injection all of which were to expire 12/1/11.

c. Three 5 ml PFS of lidocaine 2% for injection two of which were to expire 7/1/12 and one of which was to expire 8/1/11.

d. Thirty-six 100 ml vials of sterile water for injection, four of which were to expire 4/1/12, eight of which were to expire 6/1/12, while the rest were to expire after the posted expiration date.

The expiration dates posted outside of the MH Cart on the content list were as follows:

e. Sodium bicarbonate: 5/30/12 (29 days later than the manufacturer's expiration date).

f. Furosemide: 12/30/12 (29 days later than the manufacturer's expiration date).

g. Lidocaine: 8/30/11 and 7/30/12 (29 days later than the manufacturer's expiration dates for each medication).

h. Sterile water for injection: 6/30/12 (almost three months after the earliest recorded manufacturer's dates found on four vials in the cart).

The content list mislabeled the expiration dates of the medications contained in the MH Cart.

3. On 4/25/11 at 4:32 p.m. during an inspection of Warmer A and Warmer B in the Surgery Department, the surveyor found one 1500 ml plastic pour bottle of sterile water for irrigation (used for irrigation purposes) in Warmer A with a tag on which staff had written 4/18/11 and the surveyor found one 1000 ml plastic pour bottle of normal saline (0.9% sodium chloride used to irrigate surgical wounds) in Warmer B with a tag on which staff had written 2/16/11 and a second bottle with no date tag on it. These bottles were stored at 100.4 deg F in Warmer A and 104 deg F in Warmer B. Baxter, the manufacturer of these solutions has indicated that these solutions can be stored for 30 days at temperatures not to exceed 104 deg F at which time they must be removed from the warmer. During an interview of Administrative Nurse NNN at that time, she stated that the dates on the bottles were the dates that staff was to remove the bottles from the warmer. Therefore, for one bottle it was not possible to tell when it would expire while two bottles were expired rendering all three bottles unusable for patients.

4. On 4/25/11 at 4:32 p.m. during an inspection of Warmer D in the Surgery Department, the surveyor found it contained forty-nine (total combined count) 1000 ml intravenous (IV) bags of normal saline and lactated ringers (used for IV fluid replacement) all manufactured by Baxter. Baxter has documented that the IV solutions it makes can be stored for 14 days at temperatures up to 104 deg F and then must be removed from the warmer. A total of six of these bags (four lactated ringers and two normal saline) had no date tags placed on them (the rest of the IV bags all had date tags) making it impossible to tell how long these solutions had been in the warmer and rendering them unusable for use on patients in the hospital.

5. On 4/25/11 at 2:50 p.m. an inspection of the 5th Floor Medical Surgical Nursing Unit Crash Cart indicated it contained two 1 ml vials of heparin 1000 units/ml. On 4/25/11 at 2:54 p.m. an inspection of the 4th Floor Medical Surgical Nursing Unit Crash Cart indicated it contained two 1 ml vials of heparin 1000 units/ml. On 4/25/11 at 3:07 p.m. an inspection of the Post Anesthesia Care Unit Crash Cart indicated it contained two 1 ml vials of heparin 1000 units/ml. On 4/28/11 at 3:33 p.m. an inspection of the outpatient Pavilion Surgery Department Crash Cart indicated it contained two 1 ml vials of heparin 1000 units/ml. The external content list on all of these carts documented the cart contained "2 heparin" in Drawer 4 which would not provide staff any direction as to what should be placed and/or found in the cart. Heparin is available in various concentrations and in containers of various volumes.

Based on food storage observations and dietary staff interview the hospital failed to ensure 1) an effective dating system for thawing raw meat and 2) effective storage of spices as evidenced by the lack of dating when opened.

Findings:

1) During initial tour on 4/25/11 beginning at 11 am, it was noted that in the walk-in refrigerator there was raw beef and cooked turkey stored on the same shelf. In a concurrent interview with Dietary Management Staff (DMS) I he stated that the cooked and raw items should not have been stored on the same shelf.

It was also noted that in the refrigerator there were 2 pans of marinating raw chicken, one of which had a use by date of 4/25 and the second with a use by date of 4/27. In a concurrent interview with Dietary Staff (DS) JJJ he stated that all of the chicken was pulled from the freezer on 4/24. The surveyor asked him to explain why there was a difference in dates of the items. He was unable to explain why the items were dated differently. Review of hospital policy titled "Dating Refrigerated/Frozen Foods" dated 1/11 guided staff that "Frozen ...meat (not pre-cooked) should be thawed in a refrigerator ...Use immediately and do not refreeze." It was also noted that the hospitals' food storage guidelines were not consistent with the policy. The food storage guidelines noted that fresh poultry could be retained for 2-3 days.

2) During the initial tour on 4/25/11 beginning at 11 am, in the dry storage, it was noted that there were metal canisters containing salt, seasoned salt and corn starch with no date. In a concurrent interview with DMS I he stated that the items were received in bulk and put into the metal canisters. He also stated he was unable to demonstrate how long the items were in the canister. Review of hospital policy titled "Dry Storage" guided staff that "All food will be dated-month, day, year ..."

3) During the initial tour on 4/25/11 beginning at 11:00 a.m., in the catering area, there were undated plastic containers with bulk quinoa, coconut and barley, as well as opened, undated containers of the spices cloves, sumac, and green cardamon. Hospital "Dry Storage" policy required "All food be dated with month, day, year."



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Based on medical record review and interview, the hospital failed to ensure the nutritional needs of 1 patient (Patient 252) in a sample of 3 patients, reviewed for nutritional care, as evidenced by the lack of review by physicians' for nutritional recommendations. Lack of an effective system to ensure comprehensive planning for patient nutritional needs may further compromise the clinical and nutritional status of patients.

Findings:

Patient 252 was admitted with diagnosis including small bowel obstruction. Admission diet order was NPO (nothing by mouth). A follow up diet order dated 4/6/11 noted the initiation of total parenteral nutrition (TPN-feeding through a vein). Admission height was 5 feet 8 inches and weight was 112 pounds. It was also noted that the patients' body mass index (BMI) was 16.64 which is a measure of fat in relationship to a patients' height and weight. BMI's of 19 or below may be indicative of compromised nutritional status (World Health Organization, 2011). Lab work dated 4/5/11 noted an albumin (a measure of protein stores) of 1.8 gm/dl (normal 3.5-5.0 mg/dl). A comprehensive nutrition assessment dated 4/8/11 noted that the patient had a depleted vitamin D level of 22 ug/dl (normal 30-95 gm/dl). The assessment also recommended Vitamin D supplementation of 3,000 units/day. A follow up nutrition assessment dated 4/12/2 again recommended supplementation. Similarly there were nutritional recommendations dated 4/17 and 4/22/11 regarding the possibility of implementing enteral feeding (feeding through a nasal tube into the stomach) in an effort to maintain gut function. There was no documentation that the physician(s) responsible for the care of the reviewed and/or acknowledged the registered dietician's (RD's) recommendations.


In a concurrent interview with DMS JJ she was asked to describe how RD's followed up on nutritional recommendations to physicians. She stated that within the electronic medical record the RD's had the ability to put in recommended interventions. She also stated that the RD's would rely on the physician to review the recommendations. The surveyor asked that if it did not appear that recommendations were reviewed would the RD's contact the physician. She stated that likely they would not. Hospital policy titled "Clinical Dietitian Recommendations" dated 11/09 revealed that the procedure for nutritional recommendations would be for the RD to write the nutritional intervention on the physicians' order page and stamp the page with the options of implementation or decline of the intervention. There was no indication the RD documented the recommended interventions per hospital policy, rather the RD charted the recommendations on a form titled "Multidisciplinary Recommendation Form for MD." It was also noted that this form was not intended to part of the permanent medical record.

Based on food storage observations and dietary staff interview, the hospital failed to ensure that all necessary patient equipment was maintained as evidenced by the integrity of the wainscoting in the walk-in refrigerator. Failure to ensure the quality of the interior or necessary patient equipment may result in bacterial growth behind the surfaces exposing foods to potential cross contamination.

Findings:

During the initial tour on 4/25/11 beginning at 11 am, it was noted that the plastic wainscoting, measuring 5-6 inches wide and 6 feet tall, along the entrance of the walk-in refrigerator was buckling away from the door jam, exposing a brown-rust like material. It was also noted that the joints of the wainscoting were exposed resulting in a surface that was not smooth and cleanable. In an interview on 5/26/11 at 10 am, with DMS I he stated acknowledged that the surface was no longer in tact. He also stated he was aware of it; however to date had not implemented any corrective action. It would be the standard of practice to ensure that all non-food contact surfaces were free of unnecessary crevices, ledges and projections and were constructed to facility cleaning (Food Code, 2009).

Based on observations and staff interview the hospital failed to ensure: 1.) Food storage practices maintained the integrity of the food supply as evidenced by the retention of severely dented cans. Retention of severely dented cans may result in patient exposure to food borne illness as a result of microbial growth within the compromised cans. 2.) The ice machine in the kitchen was clean and sanitized following manufacturer's specifications. This failure may lead to food-borne illness. Foodborne illness may result in further compromise of clinical condition and in severe instances may result in death. 3.) That intravenous tubing (IV) for one randomly selected patient was kept off the floor and free of contamination. This potentially could result in contaminants reaching the port of the tubing and entering the intravenous tube and therefore entering the patient's blood system.

Findings:

1.) During initial tour on 4/25/11 beginning at 11 am, it was noted that in the dry storage area there were #10 cans of bamboo shoots and refried beans that were dented. In a concurrent interview with DS F, who had supervisory responsibility for the storeroom stated that the dented cans should have been removed at the time of unpacking, rather than placing them in the general supply. Hospital policy titled "Dry Food Storage" dated 1/19/11 guided staff that "Dented cans are stored in designated areas ...)

2.) On 4/25/11 during the initial tour of the kitchen at 11:30 a.m., the ice machine cleaning procedures were reviewed with Engineering Staff S, responsible for the cleaning and sanitizing the machine monthly. Engineer stated he "cleans it if it needs it" and that he used "bleach" to sanitize the machine and the ice bin. The white ice deflector on the inside of the ice bin was observed to have an orange/brown residue that could be wiped off with a clean paper towel. During concurrent demonstration, Engineer S provided the bleach used to sanitize the machine and the bleach label did not reveal it was approved for porous and non-porous food contact surfaces such as an ice machine. Engineer S acknowledged the ice machine was not clean and that the cleaning and sanitizing procedures he used did not follow manufacturer's guidance.




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3.) On 4/25/11 at 12:05 p.m., Director of the Medical Surgical Unit Licensed Staff BBB was questioned whether or not she had in-serviced the hospital staff regarding intravenous tubing on the floor. She stated she had inserviced the staff and provided a copy of an MSU (medical surgical unit) Team Meeting minutes dated 10/28/10 which indicated "State Survey Results" under the heading titled of "How are we doing?" The copy of the meeting minutes did not contain any information regarding infection control and keeping the IV tubing off of the floor during use. The minutes indicated that out of 93 Registered Nurses, Licensed Vocational Nurses, and Certified Nursing Assistants, only 39 of those staff attended the in-service. Licensed Staff BBB also stated she only in-serviced the staff in the medical surgical unit and the orthopedic unit and was not aware that she was supposed to have in-serviced the other units which provided nursing care to patients with IV tubing.

On 4/25/11 at 1:45 p.m., during a tour of the facility, Room 427 was occupied by a patient who recently had surgical intervention. He was receiving medication which required IV tubing. The IV tubing between the pole and the patient was lying on the floor. Licensed Staff CCC, who was at the nurses station, which was close in proximity to Room 427 was asked to observe the patient's IV tubing. She stated that the tubing should not be on the floor.




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