Summary:
Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the New England Sports, Orthopedics, Spine, & Rehabilitation laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to ensure that temperature conditions were consistent with manufacturer's instructions for reliable test system operation as evidenced by the following: Refrigerator storage: a) A review of the laboratory's procedure for storage of specimens indicated storage of specimens for up to seven (7) days at two (2) to eight (8) degrees Celsius. b) Review of 6 package inserts for the drugs being tested (amphetamine, benzodiazepine, cocaine, methadone, opiate, and oxycodone) indicated that storage of specimens was acceptable up to three (3) days. b) Record review of eight patient results for testing performed between 4/30/18 and 9/18/18 revealed that patient testing was performed on specimens that had been stored more than three days refrigerated (patient number 8 collected on 9/13/18 and tested on 9/18/18 - five days later). c) Interview with the technical consultant on 10/4/18 at 9:35 AM revealed that the laboratory had utilized Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines for storage of specimens prior to testing. Laboratory Freezer temperature: a) Review Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- of 6 package inserts for the drugs being tested (amphetamine, benzodiazepine, cocaine, methadone, opiate, and oxycodone) indicated that specimens being frozen should be stored at minus 20 degrees Celsius. b) A review of the laboratory freezer temperature records since the laboratory opened (thirty seven (37) days of laboratory operation) revealed that the temperature of the freezer was above the acceptable range for fourteen (14) (4/24, 5/3, 5/14, 5/23, 5/29, 6/5, 6/13, 6/18, 6/27, 7/5, 7/11, 7/29, 8 /18, and 9/6/18) of the thirty seven (37) day of laboratory operation. The laboratory had indicated an acceptable temperature range of minus five(5) to minus thirty (30) degrees Celsius on the temperature charts versus utilizing the acceptable range indicated by the manufacturer. The temperature of the freezer on 10/4/18 at 9:40 AM was observed to be minus 14.4 degrees Celsius c) The laboratory technologist stated in an interview on 10/4/18 at 12:10 PM that the freezer had not been utilized for the storage of specimens until mid August and September. d) Based on the laboratory not following manufacture's instruction regarding storage of specimens, the stability of specimens stored in the refrigerator and freezer could not be assured. The laboratory performs approximately 14,112 drug screens annually. . D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to have a record system which included the identity of the personnel who performed the test(s) as evidenced by the following: A review of eight (8) patient electronic medical records for laboratory testing performed between 4/30/18 and 9/18/18 revealed that the identity of the person performing the testing was not indicated on the laboratory's final report for all eight (8) records reviewed. Observation of the laboratory analyzer setup information on 10/4/18 at 10:48 AM confirmed that the operator identification for entry on final reports was disabled on the analyzer. The laboratory technologist confirmed in an interview on 10/4/18 at 10:50 AM that the identity of the person performing the testing was not being documented anywhere in the laboratory record system. -- 2 of 2 --