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. Author manuscript; available in PMC: 2015 Jul 29.
Published in final edited form as: Clin Biochem. 2012 Jun 29;45(0):979–987. doi: 10.1016/j.clinbiochem.2012.06.023
Bibliographic Information
- Author (s)
- Yr Published/Submitted
- Publication
- Author Affiliations
- Funding
Study
- Design
- Facility/Setting
- Time Period
- Population/Sample
- Comparator
- Study bias
Practice
- Description
- Duration
- Training
- Staff/Other Resources
- Cost
Outcome Measures
- Description (s)
- Recording method
Results/Findings
- Type of Findings
- Findings/Effect Size
- Stat. Significance/Test(s)
- Results/Conclusion Bias
Geisinger Medical Center, Danville, PA, USA

- Year: 2009

- LMBP Network Submission

- Funding: Self-funded
- Design: Before-After

- Facility/Setting: Geisinger Medical Center, Danville, PA; teaching hospital with > 300 beds; >1 million tests/yr.

- Time period: 1/2006--6/09
Pre: 2006 (12 mos.)
Post: 1–6/2009 (6 mos.)

- Population/Sample: Avg. 70 CV calls/day to inpatient units and ER. All CVs excluding Anatomic Pathology reported for GMC testing population;
Post: 12,306 CV calls;
Pre: sample size not reported.

- Comparator: Passive system used by bench technologists using a written call log with no readback verification

- Study bias: None noted
- Description: Call center operates 24 hrs./7 days/wk. and is staffed by 21 FTEs. A centralized Client Service Contact Center with an integrated software application make critical value calls directly to a licensed practitioner who can take action on critical values. The Call Center must also verify and document readback of the critical value. The time interval is measured from the identification of the verified critical value to the receipt by the responsible licensed care giver.

- Duration: 1/07 - practice ongoing

- Training: Education materials provided

- Staff: Call Center staff

- Other resources: None reported

- Cost: Not reported
- Description: (1) Timeliness of reporting – Pre: written call log by bench technologists with no readback verification of critical values being called to someone: not necessarily a care provider.
Post: % CV results reported within 30 min interval from identification of the verified critical result to acknowledgement by responsible licensed caregiver.

- Recording Method: Vendor occurrence/ monitoring; No reliable method of tracking comparator rates (2006) as no monitoring system was in place to ensure that the results were given to care providers nor was there documentation of the readback of results.
- Type of Findings: Pretest-Postest

- Findings/Effect Size: (1) % CV results reported within 30 min to responsible licensed caregiver
Pre (2006): 50%
Post (2009): 95.5%

Inline graphic d = 1.684 (CI = 1.635–1.733)
Inline graphic OR = 21.2 (CI = 19.4 – 23.2)

- Statistical Significance/Test(s): Not reported

- Results/conclusion biases: Data collected during notably different time periods (2006 and 2009); data not provided to support findings or statistical analysis
Quality Rating: 6 (Fair) (10 point maximum)
Effect Size Magnitude Rating: Substantial
Relevance: Direct
Include: expected downward bias from different measures not apparent
Study (3 pts maximum): 3 Practice (2 pts maximum): 2 Outcome measures (2 pts. maximum): 0
Different measures used to estimate rates
Results/findings (3 pts maximum): 1; - Appropriateness of statistical analysis: Compares two practices with estimates based on data from notably different time periods - Data insufficient to allow/verify calculation of an effect size (no sample sizes reported)
Providence Regional Medical Center, Everett, WA, USA

- Year: 2009

- LMBP Network Submission

- Funding: Self-funded
- Design: Observational

- Facility/Setting: Providence Regional Medical Center in Everett, WA; > 300 beds; >1 million tests/yr.

- Time period: 10/08–6/09 (3 consecutive calendar quarters)
2008- 4th qtr: 10/08–12/08
2009 -1st qtr: 1/09–3/09
2009- 2nd qtr: 3/09–6/09

- Population/Sample:
Call center: 108 outpatient only hospital CV calls
Comparator: 1,162 inpatient only hospital CV calls

- Comparator: Inpatient CV test results communicated by laboratory techs

- Study bias:
- Description: Critical values results communicated by client services call center to designated physician or clinic staff.

- Duration: 10/08–6/09

- Training: Client services staff trained on call center management software

- Staff: Not reported

- Other resources: Not reported

- Cost: Not reported
- Description: Timeliness of reporting - % CV results reported within 15 min.

- Recording Method: Occurrence log
- Type of Findings: Comparison: Call Center (outpatient) v. Techs (inpatient)

- Findings/Effect Size:
Timeliness within 15 min- 2008-4th qtr:
Call Center: 97% (n=29); Techs: 99.8% (n=427)
2009 – 1st qtr
Call Center: 97% (n=32); Techs: 98% (n=329)
2009- 2nd qtr:
Call Center: 60% (n=47); Techs: 99% (n=406)

Inline graphic ES = Not calculable from the data provided

- Statistical Significance/Test(s): Not reported

- Results/conclusion biases: Sample selection may explain unfavorable direction of results
Quality Rating: 3 (Poor) (10 point maximum)
Effect Size Magnitude Rating: N/A
Relevance: Direct
Study (3 pts maximum): 0; - Samples for the practices are sufficiently different to clearly nullify generalizability of the results – small number of outpatient only CV calls for call center vs. large number of inpatient only CV calls for comparator Practice (2 pts maximum): 1; - An important aspect of implementation not well-described; staffing not reported Outcome measures (2 pts. maximum): 2 Results/findings (3 pts maximum): 0; - Sample sufficiency: Statistical power is not discussed AND the sample is likely too small to allow a robust estimate of the impact of a practice - Appropriateness of statistical analysis: Does not provide data sufficient to allow/verify calculation of an effect size
Saxena S (1,2); Kempf R (2), Wilcox S (2), Shulman IA (4), Wong L (2), Cunningham G (2), Vega E, Hall S (2)
- Year: 2005
- Publication: Joint Comm J Qual Patient Saf.
- Affiliations: [1] Keck School of Medicine, University Southern California. [2] Los Angeles County + University of Southern California Healthcare Network.
- Funding: Self-funded
- Design: Cross-sectional
- Facility/Setting: LA County and Southern Calif Medical Center. Urban, acute care teaching hospital, >700 beds.

- Time period:
Pilot: 04/2003
Implementation: 11/2003 – 05/2004
Post: 12/2004

- Population/Sample:
All CV notifications
Pre: Not reported
Post: between 334–700; approximately 86% inpatients; 14% outpatients
- Comparator: Direct physician notification of critical laboratory values.
- Study bias: Both practice and comparator include call center practice
- Description: Centralized and standardized user-friendly system for notification of critical laboratory values (CLVs). Lab tech calls customer service center (CSC) staff who directly communicates CLVs to physician.

- Duration: 8 months (5/2004 – 12/2004)

- Training:
10 hrs. training CSC staff to use system
- Staff: Interdisciplinary team with lab services director (network’s associate patient safety officer) as team lead; medical center lab director, assistance chief administrative labo manager, lab quality improvement coordinator, information tech representative, customer service center supervisor, and medical director of ambulatory services.
- Other resources: Not reported
- Cost: 230 hours IT time over 5-month period for development
- Description:
(1) Time to receipt of CV result in minutes
(2) Timeliness of reporting - % CV results reported within 1 hour
(3) Timeliness of reporting – % CV results reported within 15 min
- Recording Method: Progress reports to the network’s quality improvement committee (QJC), chaired by chief medical officer
- Type of Findings: Pretest-Posttest

- Findings/Effect Size:
(1): Monthly average CV lab test notification time:
Pre: 38 minutes
Post: 10 minutes
(2) Noncomparative: For May 2004- December 2004, almost all (99%–100%) notifications were completed within one hour
(3) Noncomparative: –For May 2004- December 2004, 79%–83% of notifications were completed within 15 minutes.
Inline graphic ES = Not calculable from the data provided

- Statistical Significance/Test(s): Not discussed

- Results/conclusion biases: No data sources provided for outcomes reported; no comparison period sample size reported; findings only compare last month before implementation with last month of measurement.
Quality Rating: 7 (Fair) (10 point maximum)
Effect Size Magnitude Rating: Substantial
Relevance: Direct
Study (3 pts maximum): 2
Potential study bias: sample selection (includes emergency patients CV) may introduce a study bias that would affect results (−1)
Practice (2 pts maximum): 2 Outcome measures (2 pts. maximum): 2 Results/findings (3 pts maximum): 1
Sample sufficiency: Number of pre sample not reported (−2)
- Unpublished Study A

- Year: 2008

- LMBP Network

- Eastern USA

- Funding: Self-funded
- Design: Before-after
- Facility/Setting: Large urban academic medical center in Mid- Atlantic U.S. with more than 600 beds; annually > 32,000 inpatients; 300,000 outpatients
- Time period: Approximately 2 mos.; 1 mo. pre-call center (3/26–4/27/08) and 1 mo. post- call center (4/28–5/28/08)
- Population/Sample: No sample size reported. Approximately 200 CV calls/day – likely inpatient only - includes all CV test results within time period, however does not include all patients since call center not implemented in all areas – no details provided
- Comparator: Computer call queue software tracks time to report CVs to licensed caregivers without using call center. No other information on pre- call center practice; may have involved nursing staff receiving CV test results from lab and calling physicians.
- Study bias: None
- Description: Call center operates 24 hrs./7 days/wk with a 1 hour target threshold for all CV calls. Lab-certified CV test results go into call center computer queue for its staff to call licensed caregivers. Call Center staff asks caregiver to read-back the results and documents the read-back in the computer system. Utilizes escalation procedure to identify patient caregiver.

- Duration: 1 month (Practice initiated on 4/28/08)

- Training: Not discussed
- Staff: Staffed by 1–3 medical technologists per shift
- Other resources: Not noted

- Cost: Not reported
- Description:
(1) Timeliness of reporting - % daily CV results reported within 1 hour
(2) Time to receipt of result - Average daily time (min.) per CV test result notification (i.e., to report to licensed caregiver)
- Recording Method: Person making call asks caregiver to read-back results. The read-back is recorded in the computer system, which tracks time from when result certified until caregiver notified (CV “TAT”)
- Type of Findings: Pretest-Posttest:

- Findings/Effect Size:
(1) % CV results reported within 1 hour:
Pre: 76.7% daily average (SD: 13.74; Variance: 188.69; Range: 37.5 – 95.3% daily)
Post: 92.1% daily average (SD: 5.35; Variance: 28.62; Range: 71.6 – 99% daily).
(2) Noncomparative:
Pre-Call Center only (3/26–4/21/08):
Avg. daily CV notification time: 46.5 minutes (SD: 25.53; Range: 21 – 157); removing the single 157 min. outlier: 42.1 minutes (SD 12.25)
Inline graphic d = 0.697 (CI = 0.149–1.543)
Inline graphic OR = 14.1 (CI = 5.2 – 38.4)

- Statistical Significance/Test(s): Not reported

- Results/conclusion biases: No comparisons available on differences between areas where call center was and was not implemented.
Quality Rating: 7 (Fair) (10 point maximum)
Effect Size Magnitude Rating: Substantial
Relevance: Direct
Study (3 pts maximum): 2
Study sample may not be representative of practice; call center not implemented hospital-wide; no information on population
Practice (2 pts maximum): 2 Outcome measures (2 pts. maximum): 2 Results/findings (3 pts maximum): 1
Sample sufficiency: measurement period may be insufficient to allow robust estimate of impact. Appropriateness of statistical analysis: does not provide data sufficient to allow/verify calculation of an effect size (sample size)
- Unpublished - Call Center: Study B

- Year: 2009

- LMBP Network Submission

- Western USA

- Funding: Self-funded
- Design: Time-series

- Facility/Setting: Western USA, Large Health Maintenance Organization (HMO) Laboratory; > 300 beds; >1 million tests/yr.

- Time Period: Pre: June 2004; Post: June–July 2009

- Population/Sample: A sample of 500–750 CV test results/mo; study population was CVs for routine outpatient laboratory work. Inpatient or STAT excluded. No sample sizes reported.

- Comparator: Original CV protocol: Regional Lab notified collection laboratory which then notified provider.

-Study Bias: None
- Description: Call center operates 24 hrs./7 days/wk. 24/7 Adult & Advice Call Center that was already staffed with Advice RNs and Call Center MDs who were rotating Emergency Physicians. Two tracks were created, one for INR CVs and one for all other lab CVs

- Duration: 3/09 - ongoing

- Training: Not discussed

- Staff: Staffing level unknown; skilled nursing staff call center; lab assistants occasionally assist in notification.
- Other Resources: Not reported
- Cost: Not reported
Outcome Measure: Timeliness of reporting – % CV results reported within 1 hour

- Recording Method: Internal quality control instrument; audit of electronic medical record
- Type of Findings: Time series

- Findings/Effect Size:
Timeliness of reporting (within 1-hr)
N = 550–750 CVs monthly (2009)
Pre: June 2004: 49.2% (~320) CVs reported within 1 hour (# of calls estimated - based upon range in 2009)
Time 2 (June–July 2009): June–July 2009: 100% of approximately 1,300 CVs reported within an hour

Inline graphic d = 3.826 (CI = 2.9874 – 4.778)
Inline graphic OR = 1031.5 (CI = 183.5 – 5799.2)

- Statistical Significance/Test(s): Not reported

- Results/conclusion biases: Actual Ns not reported
Quality Rating: 8 (Good) (10 point maximum)
Effect Size Magnitude Rating: Substantial
Relevance: Direct
Study (3 pts maximum): 3 Practice (2 pts maximum): 2 Outcome measures (2 pts. maximum): 2 Results/findings (3 pts maximum): 1
- Number of subjects not reported; time periods notably different
University of Maryland
- Year: 2008
- Publication: Unpublished
- Affiliations:
- Funding: Self-funded
- Design: Longitudinal
- Facility/Setting: U Maryland Medical Center. Urban, acute care teaching hospital, >700 beds.

- Time period:
Pre: 3/28/08 – 4/27/08
Post: 4/28/08 – 5/14/08 (two days omitted from calculations as call center was not staffed)

- Population/Sample:
All CV notifications
Pre: Approximately 6,600
Post: Approximately 3,000
- Comparator: Direct physician notification of critical laboratory values. ????
- Study bias:
- Description: When a critical result is certified, it goes into a call queue, which goes to the call center.
- The information is color-coded on the computer screen of the person making the calls, depending on how long the result has been available: results coded yellow have been available (and waiting to be called) for less than 30 minutes. (All results start in yellow in the system.); results coded red have been available (and waiting to be called) for more than 30 minutes.

- Duration: 48 days (3/28/08 – 5/14/08)

- Training:
10 hrs. training CSC staff to use system
- Staff: The call center operates 24 hours per day, 7 days a week. The call center is not yet fully staffed. When fully staffed, it will have 2 med techs for each day shift, and one for off-shifts and a total of 7 staff

- Other resources:
- Cost:
- Description:
Timeliness of reporting - % CV results reported within 1 hour to licensed caregiver; - first call is to call the ordering physician. If that person cannot be reached, then they call the floor where the patient is located and ask to speak to the person taking care of the patient at that time.

- Recording Method:
-The person making the call asks the caregiver to read- back the results. The read- back (including who was called and when) is then documented in the computer system.
- Type of Findings: Pretest-Posttest

- Findings/Effect Size:
Percentage of calls within 1 hour:
Pre: 76.7 (SD = 13.7)
Post: 95.7 (SD = 2.1)

Inline graphic d = 1.665 (CI = 1.616–1.714)
Inline graphic OR = 20.5 (CI = 18.7 – 22.4)

- Statistical Significance/Test(s): None

- Results/conclusion biases:
- Short measurement period, but sufficient as critical values were not rare events.
Quality Rating: 8 (10 point maximum)
Effect Size Magnitude Rating: Substantial
Relevance: Direct
Study (3 pts maximum): 2
Potential study bias: sample selection (includes emergency patients CV) may introduce a study bias that would affect results (-1)
Practice (2 pts maximum): 2 Outcome measures (2 pts. maximum): 2 Results/findings (3 pts maximum): 2
Number of subjects not reported