Helix Specialty Diagnostics

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on lack of laboratory personnel credentials and interview, the laboratory failed to employ a laboratory director (LD) who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction of the laboratory. The laboratory failed to employ a qualified LD since August 31, 2023. The laboratory ceased all laboratory testing on August 31, 2023. (Refer to D6078) D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical 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 -- residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on interview with the technical supervisor (TS) the laboratory failed to ensure a qualified laboratory director is employed. Findings: 1. Interview with the TS on September 12, 2023 at 9:30 AM stated the previous laboratory director resigned on August 31, 2023. The laboratory ceased all laboratory testing on August 31. 2023. 2. Interview with the TS on September 12, 2023 at 9:30 AM confirmed the laboratory failed to ensure the laboratory employed a qualified laboratory director. D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory personnel credentials and interview, the laboratory failed to employ a clinical consultant who meets the requirements of 493.1455 of this subpart and provides clinical consultation to the laboratory. The laboratory failed to employ a qualified clinical consultant since August 31, 2023. The laboratory ceased testing on August 31, 2023. (Refer to D6135) D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3)(i) or, for the subspecialty of oral pathology, 493.1443(b)(6); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on interview with the technical supervisor (TS) the laboratory failed to ensure a qualified clinical consultant is employed. Findings: 1. Interview with the TS on September 12, 2023 at 9:30 AM stated the previous laboratory director (whom is also the clinical consultant) resigned on August 31, 2023. The laboratory ceased all laboratory testing on August 31, 2023. 2. Interview with the TS on September 12, 2023 at 9:30 AM confirmed the laboratory failed to ensure the laboratory employed a qualified clinical consultant. -- 3 of 3 --

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 lack of documentation of verification of accuracy for the Quant Studio 12k Flex PCR and interview with the technical supervisor (TS), the laboratory failed to verify accuracy of eighteen of eighteen organisms twice annually. Findings: 1. Review of Quant Studio 12k Flex PCR verification of accuracy showed no documentation for the organisms acinetobacter baumannii, candida albicans, cirobacter freundii, enterobacter aerogenes, enterbacter cloacae, esherichia coli, enterobacter faecalis, enterobacter faecium, kiebsiella oxytoca, kiebsiella pneumoniae, morganella morganii, pseudomonas aeruginosa, proteus mirabillis, providencia stuartii, proteus vulgaris, streptococcus agalactiae, staphylococcus aureus and strapylococcus saprophyticu. 2. Interview with the TS on December 15, 2020 at 11:45 AM confirmed the laboratory failed to verify the accuracy of eighteen organisms twice annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of 2019/2020 temperature logs, Quant Studio 12k Flex PCR manufacturer instructions and interview wit the technical supervisor (TS), the laboratory failed to monitor room temperature. Findings: 1. Review of temperature logs showed no room temperature documented in the room containing the Quant Studio 12k Flex PCR from December 11, 2019 to December 15, 2020. 2. Review of Quant Studio 12k Flex PCR manufacturer instructions states temperature range of 4- 99.9 degrees Celsius required. 3. Interview with the TS on December 15, 2020 at 11: 45 AM confirmed the laboratory failed to monitor room temperature. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of 2019/2020 Quant Studio 12k Flex PCR quality control (QC), patient reports and interview with the technical supervisor (TS), the laboratory failed to perform a positive and negative QC material each day of patient testing for 17 of 18 organisms. Findings: 1. Review of 2019/2020 Quant Studio 12k Flex PCR QC showed no documentation of QC for the organisms: acinetobacter baumannii, cirobacter freundii, enterobacter aerogenes, enterbacter cloacae, esherichia coli, enterobacter faecalis, enterobacter faecium, kiebsiella oxytoca, kiebsiella pneumoniae, morganella morganii, pseudomonas aeruginosa, proteus mirabillis, providencia stuartii, proteus vulgaris, streptococcus agalactiae, staphylococcus aureus and strapylococcus saprophyticu. 2. Review of patient reports from December 11, 2019 to date December 15, 2020 showed 335 patients results were reported on 207 runs. 3. Interview with the TS on December 15, 2020 at 11:45 AM confirmed the laboratory failed to perform a positive and negative QC material on each organism on the Quant Studio 12k Flex PCR each day of patient testing. -- 2 of 2 --