San Diego Reference Laboratory

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) result reports and interviews with the laboratory's testing personnel (TP) it was determined that the laboratory failed to enroll and participate in a proficiency testing (PT) program that meets the criteria in subpart H of 42 CFR part 493 and is approved by HHS. The findings included: 1. The laboratory performed hematology procedures and failed to show evidence of enrollment in a PT program for hematology subspecialties using a CMS approved PT program for the year 2023. The laboratory analyzed and reported tests for hematology cell blood count (RBC, WBC, hemoglobin, hematocrit, and platelet count) patient test results during the time of non-enrollment in a proficiency testing (PT) program. 2. The laboratory staff confirmed on July 11, 2024, at approximately 1:50 p. m. that patient test results for hematology were analyzed and reported, yet the laboratory had not enrolled in an accredited PT hematology for the year 2023. 3. The laboratory annual testing declaration signed by the LD estimated total volume of hematology 123,255 tests annually. D3003 FACILITIES CFR(s): 493.1101(a)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour and interview with the laboratory's testing personnel (TP) and the laboratory manager (LM) on July 11, 2024; it was determined that the laboratory failed to minimize contamination of patient specimens, equipment, and materials used during specimen processing of samples for the detection of drugs of abuse in urine and saliva. The findings include: 1. During the laboratory tour at approximately 3:15 p.m. the surveyor observed the area assigned for urine and saliva sample accessioning, processing (opening tubes), and sample labelling for drug testing test took place in the same area/desk where the computer was used, and paperwork was manipulated by personnel not wearing personal protective equipment (PPE). 2. During an interview on July 11, 2024, at approximately 3:30 p.m. the LM and TP confirmed the laboratory failed to minimize contamination of patient specimens, equipment, and desk materials, when processing samples over the same area not wearing PPE. 3. The laboratory testing declaration form on 7/11/2024 declared by the laboratory manager stated that the laboratory performs approximately 1,471,113 drug testing in urine and saliva samples 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. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory's tour, reagent materials used in the laboratory and interview with the testing personnel (TP); it was determined that the laboratory failed to label various reagents used for decontamination of surfaces to indicate the reagent's name, opening, preparation, and expiration dates when such reagents are used in the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory tour on July 11, 2024, at approximately 3:30 pm.; no opening, preparation, or expiration date labels were used or documented for various decontamination reagents used throughout the laboratory. 2. The laboratory's TP affirmed in an interview conducted on July 11, 2024, at approximately 3:45 p.m. that the following reagents: wash detergent solution and 2% bleach, were not labeled with the received date, opening, preparation, and expiration dates or documented in a reagent preparation log. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 2,081,125 for which decontamination reagents were not labelled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 7 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory tour, examination of laboratory reagents, and interview with the laboratory's testing personnel (TP); it was determined that the laboratory failed to not store and use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, July 11, 2024, at approximately 4:30 p.m. the surveyors found while touring the laboratory the following reagent used beyond its expiration date: Mineral oil Exp 03 /07/2000 Benzo IS Exp 2018 10N KOH Exp 03/26/2021 Hexane Exp 3/13/2022 Chloroform, acetic acid, ACN-MPA all Expired 2020, 2022 and 2023. 2. The TP affirmed on 7/11/2024 at approximately 4:45 p.m. the storage and possible use of reagents listed on #1 beyond its expiration date. 3. Based on the laboratory's submitted testing declaration test volume, the laboratory tests and reports approximately 1,427,236 toxicology tests samples where expired reagent may have been used. 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 the surveyor's review of the laboratory's policy and procedure, six (6) randomly chosen patient records and interviews with the technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to perform and document preventive maintenance (PM) and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for equipment used in the laboratory for sample testing. The findings included: 1. At the time of survey, based on the surveyors' observation during the laboratory tour, review of records and documentation at approximately 5:00 p.m. on July 11, 2024, it was determined that the laboratory failed to record any PM and calibration performed on the following equipment: Urine Clinitek 500 by Siemens, Eppendorf and multichannel pipettes (Serial #s 4293163, 0400800, 44258000, 0300800 Gene Mate, 792740139 VWR, Mult pipettors, 3500700015, 36337209, 742740113) used in throughout the laboratory, timers used for RPR- syphilis serology, and fume safety hoods used for the toxicology testing. 2. The TP affirmed on July 11, 2024, at approximately 5:30 p.m. that maintenance and calibration was missed for the equipment mentioned in #1. 3. According to the laboratory's testing declaration submitted by the laboratory on July 11, 2024, the laboratory performed approximately 47,820 syphilis serology, 7,196 urinalysis, and 1,722,143 toxicology samples annually for which accuracy of results cannot be affirmed. D5781