#LENCO DIAGNOSTIC LABORATORY MANUALS#
#LENCO DIAGNOSTIC LABORATORY FULL#
#LENCO DIAGNOSTIC LABORATORY SOFTWARE#

27.) The DOH’s certification procedure “is a multi-step process requiring a lab…seeking to engage in MS testing to: (i) provide a set of accurate, reproducible and scientifically robust instructions for MS testing of laboratory samples, commonly referred to as “methods ” (ii) validate these methods internally through a series of scientific experiments, patient sample simulations as well as data collection and analysis, commonly referred to as “Method Validation” and (iii) submit these methods and the standard operating procedure manuals (“SOPM”) to DOH for review and approval.” (Id.

26.) In New York, the DOH “is responsible for quality review and certification of all clinical labs, including with respect to MS testing.” (Id.

25.) In addition, according to plaintiff, MS is “a heavily regulated field of diagnostics” and “each state has developed its own regulations and procedures governing certification of labs for MS testing.” (Id. 24.) MS is “a highly complex testing process, involving sophisticated equipment and protocols that enable labs to test for chemical substances in, among other things, urine and blood - with accuracy and sensitivity significantly greater than with other, older testing procedures.” (Id. 23.) Plaintiff explains that MS is a “testing procedure that helps identify the amount and type of chemicals present in a sample by measuring the mass-to-charge ratio and abundance of gas-phase ions.” (Id.

#LENCO DIAGNOSTIC LABORATORY SOFTWARE#

22.) In 2012, “Lenco decided to add clinical toxicology to its expanding menu of diagnostic services” and thus “needed to purchase MS equipment, consisting of numerous pieces of advance technology machinery integrated with software as well as the necessary supplies, additional staff and support services.” (Id.

#LENCO DIAGNOSTIC LABORATORY FULL#

74.) Lenco claims to be “one of the largest independent clinical labs in the region, with well over 100 employees, offering a full range of diagnostic services to doctors, hospitals and individual patients.” (Second Am. It alleges, inter alia, that McKinley, a New Jersey company that acts as a selling agent for new and used laboratory equipment, made false representations to plaintiff regarding its ability to assist plaintiff with developing and certifying a mass spectrometry (“MS”) toxicology testing operation in accordance with New York State Department of Health (“DOH”) procedures. Briefly, plaintiff, a clinical laboratory based in Brooklyn, New York, commenced this diversity action on March 18, 2015. BACKGROUND AND PROCEDURAL HISTORY Familiarity with the prior proceedings is assumed. 1 For the reasons stated below, plaintiff’s motion is granted. I heard oral argument on November 22, 2019. (“defendant” or “McKinley”), the only remaining defendant in this case, opposes the motion. (“plaintiff” or “Lenco”) moves for leave to amend its Second Amended Complaint to add an alternative claim for breach of contract. MEMORANDUM AND ORDER Plaintiff Lenco Diagnostic Laboratories, Inc.

Lenco diagnostic laboratory