The Patient Centered Medical Home

The concept of the Patient Centered Medical Home (PCMH) has the potential to transform the healthcare delivery experience for both patients and providers alike. Designed to improve delivery of healthcare, patient satisfaction and cost controls, it assumes that better coordination among caregivers will result in cost savings as well as improved patient care.

Given the important role that laboratories play in allied health, there are numerous opportunities to integrate labs into the PCMH model. To assist physician office labs (POLs) in meeting the National Committee for Quality Assurance (NCQA) standards for a patient home, COLA recently prepared a comprehensive white paper report suggesting how this integration process could be successfully implemented (A copy can be found on the COLA website at Following are highlights of the research:

The PCMH Model
The PCMH concept is a healthcare model intended to establish a foundation for primary care that achieves the Institute for Healthcare Improvement’s three-fold aim of better health, better care and lower costs.[1]

To obtain recognition in medical home programs and potentially qualify for additional reimbursement from insurance providers, physician practices must undergo an assessment process and provide first contact, continuous, comprehensive, whole person care for patients across the practice, and team-based care for at least 75 percent of its patients. NCQA has the most common medical home recognition program, measuring practices on 27 elements across 6 standards.[2]

Integrating Labs into the PCMH Model
Laboratory testing is the single highest-volume medical activity with an estimated 13 billion tests performed in the United States each year.[3] About two-thirds of clinical decisions are based on laboratory test information.[4,5] As the laboratory is part of the PCMH “neighborhood,”[6] lab personnel can take the lead in establishing practices that align with PCMH standards[7] in three key areas:

• Controlling test utilization

• Identifying risks and controls for all phases of laboratory testing, including pre-analytic, analytic and post analytic

• Coordinating lab results among primary care providers, other providers in the PCMH “neighborhood” and the patient

Controlling Test Utilization
Inappropriate testing can take two forms:

• Overutilization (ordered, but not indicated)

• Underutilization (indicated, but not ordered)

Ramifications of overutilization go far beyond lab costs, unnecessary sample collection and burden on healthcare resources. Downstream effects include increased likelihood of false results leading to incorrect diagnoses, unnecessary prescription drugs, longer hospital stays and additional medical or surgical interventions.[8] Lab utilization controls that could be implemented by POLs include physician education on lab test costs and evidence-based medicine, and restricting/auditing test ordering, among others.

Identifying Risks and Controls for All Phases of Laboratory Testing
Patient safety in a point-of-care (POC) environment has been defined as, “the freedom from being placed at increased risk of injury due to either failure of the testing process, or to delayed or inappropriate responses to test results by the clinician.”[9] The total test process (TTP) is a complex chain of sub-processes that culminate in a result for the patient-and the laboratory test itself is only one cog in the chain. To help comprehend the true scope of the TTP, Lundberg defined the concept of the “brain-to-brain loop” for laboratory testing in 1975.[9]

The loop begins with the question that the clinician is addressing, followed by diagnostic test selection, sample collection, transport to the lab, analysis of the sample, reporting and interpretation of test result. The loop closes with decisions by the clinician regarding patient management.

The concept has evolved over the last 40 years; the TTP we consider today is comprised of three phases, summarized in the Table.10-14.


From a risk management point of view, a POC testing environment should have fewer pre-analytical error opportunities due to fewer steps. Nevertheless, there are greater risks for analytical errors in the POC environment associated with incomplete procedures, protocol non-compliance and insufficient tester understanding of the entire testing process, limited laboratory oversight and a lack of continuing process assessment to identify problems and make improvements.[11,15]

It is evident that labs operating in a patient-centered practice must monitor and investigate the TTP for any actual or potential adverse impact on the patient. The concept of Total Quality Management, routinely used by manufacturers, is also appropriate for application to laboratories responsible for the quality of the total testing process. Moreover, accreditation agencies require the clinical laboratory operation to have a Quality Management System and evidence that they are competently applying their Quality System to the TTP.[16]

Coordinating lab results among primary care providers, other providers in the PCMH neighborhood and the patient
The increasing use of health information technology (HIT) is key to the success of PCMH. HIT enables the practice to capture and document the entire point-of-care testing process in the patient records, including test and quality control results, billing and the clinician’s response to test results.[17]

Best practice quality system policies and procedures for reporting test results should, at minimum, address:

• Receipt of results

• Review of results and how long a reviewer has to review results

• Back-up reviewing when a primary reviewer is not available

• Reporting and confirming receipt of results by the patient, including patients that are not directly available

• Handling of abnormal results

• Reporting timeframe for critical as well as normal results

• Qualification and Training requirements for results reporting

• Quality plan for reporting process audits

Clinicians seeking opportunities to improve ordering and reporting lab tests are looking to integration of new HIT — such as handheld devices — with the capability to receive results remotely, provide electronic clinical decision support and notify physicians of alarm-level results.[18]

Finally, to facilitate the exchange of healthcare information with patients, medical record portals are proliferating, enabling patients to access their electronic health records, communicate with their health care providers, review lab results and manage medications.

Given that laboratories perform work that impacts about three quarters of diagnostic decisions affecting patients and an estimated 13 billion tests are performed in the United States each year, the ultimate success of the PCMH depends upon successfully integrating laboratories into the model. Addressing objectives such as controlling test utilization; identifying risks and controls for all phases of laboratory testing; and coordinating lab results among members of allied health teams will assist labs in achieving PCMH integration.

The Total Test Process
The total test process (TTP) is a complex chain of sub-processes that culminate in a result for the patient-and the laboratory test itself is only one cog in the chain. The concept has evolved over the last 40 years; the TTP we consider today is comprised of three phases, summarized in Table.10-14.

Dr. Daly has served as COLA’s Chief Medical Officer since 2011, where he provides professional medical knowledge and experience to represent the clinical voice in the implementation of COLA policy.


1. Institutes for Healthcare Improvement. “The IHI Triple AIM”. (accessed March 19, 2014).

2. National Committee for Quality Assurance. “Standards and Guidelines for NCQA’s Patient-Centered Medical Home (PCMH)”. (accessed March 19, 2014).

3. Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)

4. Green SF. The cost of poor blood specimen quality and errors in pre-analytical processes. Clin Biochem. 2013 Sep; 46(13-14):1175-9. PubMed

5. Plebani M. Exploring the iceberg of errors in laboratory medicine. Clin Chim Acta. 2009 Jun; 404(1):16-23. PubMed

6. AHRQ. Coordinating care in the medical neighborhood: critical components and available mechanisms. AHRQ Publication No.11-0064. June 2011. Retrieved from:

7. Miles, Joe and Ronald L. Weiss. The Role of Laboratory Medicine in Accountable Care Organizations. White Paper ARUP Laboratories. Aug 2013. Retrieved from:

8. Zhi M, Ding EL, Theisen-Toupal J, Whelan J, Arnaout R. The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis. 2013 Nov; PLoS ONE 8(11): e78962. doi:10.1371/journal.pone.0078962

9. Ehrmeyer SS, Laessig RH. Point-of-care testing, medical error, and patient safety: a 2007 assessment. Clin Chem Lab Med. 2007; 45(6):766-73. PubMed

10. Hawkins, R. Managing the Pre- and Post-analytical Phases of the Total Testing Process. Ann Lab Med. Jan 2012; 32(1): 5-16. PubMed

11. Plebani, M Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med. 2013 Jan; 51(1):187-95 . PubMed

12. Hollensead SC, Lockwood WB, Elin RJ. Errors in pathology and laboratory medicine: consequences and prevention. J Surg Oncol. 2004 Dec 1; 88(3):161-81. PubMed

13. Ric¢s C, Garc¡a-Victoria M, de la Fuente B. Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clin Chem Lab Med. 2004; 42(6):578-82. PubMed

14. Walz SE, Darcy TP. Patient safety & post-analytical error. Clin Lab Med. 2013 Mar; 33(1):183-94. PubMed

15. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol. 2011 Dec; 136(6):829-33. PubMed

16. Lippi G, Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med. 2011 Jul; 49(7):1113-26. PubMed

17. Kern, LM, Health Information Exchange and Ambulatory Quality of Care. Appl Clin Inf. 2012; 3: 197-209

18. Hickner J, Thompson PJ, Wilkinson T, Epner P, Sheehan M, Pollock AM, Lee J, Duke CC, Jackson BR, Taylor JR. Primary care physicians’ challenges in ordering clinical laboratory tests and interpreting results. J Am Board Fam Med. 2014 Mar-Apr; 27(2):268-74. PubMed

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