Curative Labs Inc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Facility Administration was not met. The findings include: 1. The laboratory failed to have adequate space necessary for conducting specimen accessioning and processing (preanalytic) and preparation of positive controls (analytic). See D3001. 2. The laboratory failed to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies was minimized. See D3003. 3. The laboratory failed to observe safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. See D3011. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on surveyors observation of preanalytic/analytic areas and interviews with the laboratory director (LD), technical supervisor (TS), and testing personnel (TP) on August 13, 2020 at approximately 10:30 a.m. it was determined that the laboratory space was not adequate to process 20,000 patients' samples per day in the preanalytic and analytic phases of the testing for SARS-CoV-2 detection. Findings include: 1. During the laboratory tour on August 13, 2020 at approximately 09:45 a.m. the surveyors observed and determined that the working space for preanalytic (specimen accessioning and processing) work was not adequate for the number of TP working in this area. a. The laboratory sample receiving-processing area of an estimated size of 3,000 sq.ft. was crowded with: approximately 30-40 TP receiving and processing specimens under the Biosafety cabinets, non-TP (maintenance staff for the removal of biohazard waste and miscellaneous non-biohazard waste), and traffic of other staff entering and exiting the room. b. There were more than one or two TP processing specimens side by side using the same Class II Biosafety Cabinet (BSC); an already crowded BSCs with processed specimens, opened sample bags, reagents, and accessioning computers. c. The specimen receiving, accessioning, and processing room consisted of a large, opened space room that served also as access to the stairway leading to the second floor testing rooms, donning and doffing of PPE, storage and pick up of waste material, and a partitioned area for sample preparation. 2. During the laboratory tour at approximately 11:00 a.m. the surveyor observed that the positive control (matrix spiked with pooled SARS-CoV-2 positive patients' samples) "spike room" was used as a general storage area for processed samples. Findings include: a. Seven TP were observed in the room putting away unlabeled boxes of processed patients' specimens. b. Unlabeled positive or negative specimen tubes were stored in opened plastic containers filled to the rim of the container in the room. c. Under the BSC used to spike the positive control were numerous smaller plastic and paper boxes more than halfway filled with previously tested samples and thus, this specific analytic work area of the laboratory had not been maintained to ensure the space necessary for conducting the positive control preparation. 3. During an interview on August 13, 2020 at approximately 11:30 a.m. the LD and TS confirmed that the space for sample processing is inadequate for the amount of TP in the room at the same time and volume of samples processed daily. 4. The LD confirmed on August 13, 2020 at approximately 11:40 a.m. that the positive control "spike room" is also used for storage of numerous already resulted sample containers due to lack of space for storage. 5. The laboratory's testing declaration form, signed by the LD on August 13, 2020, stated that the laboratory performs 2,500,000 tests annually. D3003 FACILITIES CFR(s): 493.1101(a)(2) 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 surveyor observation during the laboratory tour and interviews with the laboratory director (LD), technical supervisor (TS, and testing personnel (TP) on August 13, 2020 it was determined that the laboratory failed to minimize contamination of patient specimens, equipment, and materials used during testing for the presence of SARS-CoV-2 by the Polymerase Chain Reaction (PCR). Findings include: 1. During the laboratory tour at approximately 09:50 a.m. the surveyor -- 2 of 8 -- observed lack of decontamination at various times during specimen receiving and processing. a. Patients' specimen submitted from numerous collection sites for testing were received in different forms of packaging: non-labelled plastic bags, biohazard labeled plastic bags, plain not labelled boxes, properly labelled UN 3373 boxes, and plastic containers which were not decontaminated before opening to retrieve the individually bagged specimens. b. During sample processing under the BSC, the surveyors observed TP1 grabbed a single bag containing the specimen from the shipment container; decontaminated the outside of the bag, and teared the bag opened. Even though the absorbent paper inside the bag was moist, TP1 did not further decontaminate the bag and left the bag opened while specimen processing continued. c. The torn-opened bags were placed on top of each other and next to the rack containing the recently 70% ethanol decontaminated tubes containing the specimen to be tested. 2. During an interview on August 13, 2020 at approximately 1:45 p.m. the TS and LD confirmed the laboratory failed to minimize contamination of patient specimens, equipment, instruments, reagents, materials, and supplies for testing of the presence of SARS-CoV-2 by the Polymerase Chain Reaction (PCR). 3. The laboratory's testing declaration form, signed by the LD on August 13, 2020 at approximately 2:00 p.m. stated that the laboratory performs 2,500,000 tests annually. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyors observation of specimen processing during tour of the laboratory, review of the laboratory's policies & procedures (P&P), record review of 107 patient from April 3, 2020 to August 13, 2020, and interviews with the laboratory technical supervisor (TS) and testing personnel (TP) on August 13, 2020 it was determined that the laboratory failed to establish biosafety protocols based on risk assessment. The laboratory failed to make accessible to all employees and observe biosafety procedures to ensure protection from biohazardous materials. The laboratory had 80 out of 400 staff tested positive for SARS-CoV2/COVID19 PCR test. Findings include: 1. Based on surveyors observation of specimen processing at the time of the laboratory tour on August 13, 2020 at approximately 10:00 a.m., safety procedures to ensure protection from biohazard material were not accessible and observed by laboratory staff. a. Personal Protective Equipment (PPE): coats, gloves, goggles were not worn by all staff entering the SARS-CoV-2/COVID19 sample receiving- processing area. b. Laboratory TP returning from breaks and maintenance staff entered the sample accessioning area through the emergency exit door leading to the parking lot/street without appropriate PPE while sample processing was taking place in the Biosafety cabinets (BSC) next to the emergency door. c. The laboratory did not have a separate area for specimen receiving; both specimen receiving and specimen processing were performed in the same room. Couriers delivered patient's specimens while TP processed specimens in the same room. d. Large Biohazard labelled containers had no lids and were open at all times located at both the sample receiving- processing area and sample testing rooms. e. Processed specimens bags without any further decontamination were taken in bundles out of the BSC and discarded in an opened (no lid) Biohazard labeled container. f. Full biohazard bags were taken out of the biohazard container to be discarded by waste management outside the building -- 3 of 8 -- without decontamination. 2. Based on the surveyors observation during tour of the facility on August 13, 2020 at approximately 10:45 a.m. access to specimen accessioning, processing, and testing area took place through the same door located in the main opened, large room where all personnel passed through while initial sample processing was taking place. 3. Based on the surveyors records review of 107 patients records from April 3 to August 13, 2020 revealed 80 laboratory staff have tested positive for SARS-CoV-2 since testing began at the facility on April 1, 2020. 4. During the surveyors review of the laboratory's policies and procedures the laboratory failed to establish and make accessible biosafety protocols based on risk assessment to all the laboratory staff. 5. When interviewed on August 13, 2020 at approximately 10: 15 a.m. the laboratory TS and TP affirmed that laboratory failed to establish, make accessible, and observe biosafety procedures to ensure protection from biohazardous materials. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyors observation at the time of the laboratory tour, review of the laboratory's policies and procedures, and interview with the laboratory director, technical supervisor, and testing personnel; it was determined that the laboratory failed to monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as speciefied in 493.1249.for each specialty and subspecialty of testing performed. See D 5311 and D5391. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the surveyors observation, review of laboratory's written policies and procedures (P&P), and interviews with the laboratory director (LD) and the technical supervisor (TS) the laboratory failed to establish written policies and procedures for specimen labelling, specimen storage and preservation, and specimen transportation. Findings included: 1. Based on the surveyor review of P&P on August 13, 2020 at approximately 5:00 p.m., no written P&P were found on the following observed procedures during the laboratory tour on the day of the survey: a. The laboratory accessioning staff received patients' specimens by scanning tubes labeled with the -- 4 of 8 -- patients' demographics encoded in bar codes that were issued at the place of specimen collection. No written P&P for specimen labeling was available at the time of the survey. b. After sample processing, SARS-CoV-2 detection by RT-PCR, and after reporting of results, samples were stored at different locations, different temperatures; room temperature, frozen, or refrigerated. No written P&P on specimen storage and preservation was available at the time of the survey. c. Samples were submitted daily from multiple locations from all over the nation in different packaging materials: boxes, plastic bags, plastic containers, etc. No written procedure was available on specimen packaging and transportation. 2. Based on an interview with the LD and TS on August 13, 2020 at approximately 5:45 p.m. it was confirmed that the laboratory failed to maintain written P&P on specimen labeling, storage and preservation, and packaging and transportation. 3.. According to laboratory records, the laboratory performed approximately 2,500,000 patient tests annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on the surveyors interviews with the laboratory director (LD) and laboratory testing personnel (TP) and record review of pre-analytic remedial action records on August 13, 2020, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory's preanalytic systems when received patient specimens did not meet the laboratory's criteria for acceptability. Findings included: 1. According to laboratory TP, during the accessioning of patient specimens, if a patient specimen was received that did not meet the laboratory's criteria for acceptability, a description as to why the specimen did not meet the laboratory's criteria for acceptability would be electronically documented, applicable collecting site would be notified, appropriate