Molecular Diagnostic Laboratory Llc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to verify the accuracy bi-annually for the Urinalaysis test under the specialty of Chemistry. Findings include: 1. Surveyor observation on 04/13/2022 at 11:50 AM revealed the laboratory is using an instrument to perform Urinalysis test by Bayer Clinitek 100, Model # 5772, Serial # 124745. 2. Record review of the laboratory's proficiency testing (PT) documents on 4/13/2022 revealed: a. Lack documentation of bi-annual verification of accuracy of the urinalysis(UA) tests. b. Lack of documentation that the laboratory was enrolled in a PT program for UA tests. 3. Staff interview with laboratory director (LD) on 04/13/2022 at 12:10 PM confirmed: a. The laboratory did not enroll in the PT program for UA. b. The LD further stated he/she was under the impression the instrument used to perform the UA was a waived instrument. c. The last time Biannual accuracy verified was in 2015. 4. The laboratory performs 50 UA annually. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to label controls with the appropriate expiration dates in the subspecialty of endocrinology. Findings include: 1. Surveyor observation of the BioMerieux Vidas hCG Reagent kit, on 04/13/2022 at 10:45 AM revealed the following: a. Bio-Rad Lypochek Immunoassay Plus(BLIP) controls Level 1,2 and 3, lot # 40411, 40412 and 40413 respectively, with an expiration date of 9-30-2024 were reconstituted and in use and stored at 2 to 8 degrees Celsius. b. All the three levels of control listed above lacked the documentation when they were opened/reconstituted and date of expiration on the bottles. 2. Record review of the BLIP controls package insert 04/13/2022 revealed "when reconstituted and stored tightly capped at 2 to 8 degrees Celsius, this product will be stable as follows: All analytes: 7 days, Except: Folate and PSA(Total): 3 days, C-Peptide: 1 day and ACTH, Calcitonin, Gastrin and PSA(Free): assay immediately after reconstitution." 3. Staff interview with Laboratory Director on 04/13 /2022 at 11:59 AM confirmed that he/she was not aware of the change in expiration dates once the control materials were reconstituted. 4. The laboratory performs 559 hCG tests annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to report the the human Chorionic Gonadotropin (hCG) results within the established analytical range provided by manufacturer in the sub specialty of Endocrinology. Findings include: 1. Record review on 4/13/2022 of the Vidas HCG(HCG) package insert in the "Results and Interpretation" section revealed: "a. Samples with concentration greater than 1500 mIU/mL maybe reassayed after diluting by 1/20 to 1/200. b. If the dilution factor has not been entered when the analysis has been requested, multiply the result by the dilution factor to obtain the hCG concentration." 2. Record review on 4/13/2022 of a written email communication with the Technical Specialist at BioMerieux confirmed the reportable technical range for hCG to be 2 to 300,000 mIU/mL, and any values greater than the reportable range to be resulted as "greater than 300,000 mIU/mL". 3. Record review on 4/13/2022 of a patient report for the hCG test performed on 1/27 /2022 revealed: a. The instrument printout displayed dilution of 1:200 was performed and the result obtained was 2244.93 mIU/mL. b. The laboratory reported the above hCG results as : "448,800 mIU/mL". 3. Staff interview with the Laboratory Director on 4/13/2022 at 11:47 am confirmed: a. The technical reportable range for the hCG was 2 to 300,000 mIU/mL. b. The result (2244.93) obtained on the patient was multiplied by 200 and the value (448,800) was resulted. 4. The laboratory performs approximately 559 hCG tests annually. D5537 ROUTINE CHEMISTRY -- 2 of 3 -- CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test control material for positive and negative reactivity every day of testing, and when opening a new bottle of Siemens Multistix 10 SG Urine Reagent strips in the subspecialty of Urinalysis. Findings include: 1. Record review on 04/13/2022 of the manufacturer package insert for the Siemens Multistix 10 SG revealed under the "Quality Control" section: "Test known negative and positive specimens or controls whenever a new bottle is first opened." 2. Record review on 04/13/2022 of the Siemens Multistix 10 SG QC Record log for 2020 and 2021 revealed lack of documentation for the positive and negative control performed with each new bottle opened, each day of testing or every 8 hours. 3. Staff interview with laboratory director on 04/13/2022 at 12:10 PM confirmed that the last time the QC was performed on the instrument was in 2015. 4. The laboratory performs 50 urine analysis tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain a copy of all proficiency testing (PT) records for a minimum of 2 years. Findings include: 1. Record review on 11/14/19 of the laboratory's 2018 and 2019 American Association of Bioanalysts (AAB) PT records revealed, the laboratory failed to maintain a copy of the worksheets for antibiotic sensitivity testing for AAB 2019 survey D for Q1, Q2 and Q3 events. 2. Staff interview with the laboratory director on 11/14/19 at 11:00 AM confirmed the above findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure positive identification of a patient's specimen from the time of collection through completion of testing. Findings include: 1. Record review of the human chorionic gonadotropin (HCG) quantification instrument printout on 11/14/19 revealed the following: a. On 11 /5/19, one patient sample was labeled with first letter from patient's first and last name. b. On 10/18/19, one patient sample was labeled with first name only and three more samples were labeled with first letter from the patient's first and last name. Two more samples were labeled with first letter from the patient's first name. 2. Staff interview on 11/14/19 at 11:05 AM with the laboratory director (LD) confirmed the above findings. The LD stated it is more confusing for him/her to use the accession number and that is why letters from the patient's name were used while testing samples. 3. The laboratory performs 376 HCG quantification tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to comply with the manufacturer's maintenance recommendations. Findings include: 1. Record review on 11/14/19 of the equipment(s) preventive maintenance (PM) log revealed annual PM of the Biological Safety Cabinet (Serial # 2S-15-B-6482) was not performed in 2018. The manufacturer's recommendation revealed annual PM is required for the proper functioning of the equipment. 2. Staff interview the laboratory director on 11/14/19 at 12:15 PM confirmed the above findings. The LD stated it is difficult to get the technician to perform PM of the equipment. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to -- 2 of 3 -- identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to perform calibration verification for human chorionic gonadotropin (HCG) quantification test in the required frequency. Findings include: 1. Record review on 11/14/19 of the calibration verification records for the laboratory's Biomerieux mini-vidas analyzer used to perform HCG quantification test revealed the last calibration verification was performed on 12/19/17. 2. Record review on 11/14/19 of the Biomerieux mini-vidas analyzer operator's manual revealed calibration verification must be performed every six months. 3. Staff interview with the laboratory director (LD) on 11/14/19 at 11:20 AM confirmed the above findings. The LD stated calibration verification materials are costly. 4. The laboratory performs 376 HCG quantification tests annually. -- 3 of 3 --