Pro Diametrics Corp Dba Prodi Lab

Summary Statement of Deficiencies D0000 A recertification survey conducted from 01/23/2024 to 02/06/2024 found PRO DIAMETRICS CORP DBA PRODI LAB clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was cited: - D5300 Preanalytic Systems 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 observation, record review and interview, the laboratory failed to monitor the transport temperature of specimens delivered to the laboratory for BIOFIRE FILMARRAY Pneumonia Panel and failed to define and monitor the transport temperature for Scienetix PCR Respiratory Panel (RPP), Scienetix PCR Urinary Panel (UTI), Scienetix PCR Wound Panel and Scienetix PCR SARS-CoV-2 (COVID). Refer D5311. 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 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 -- for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: 1-Based on observation, lack of records and interview, the laboratory failed to monitor the transport temperature of specimens delivered to the laboratory for BIOFIRE FILMARRAY Pneumonia Panel testing for six out of six patients reviewed. 2- Based on observation, lack of records and interview, the laboratory failed to define and monitor the transport temperature for specimens delivered to the laboratory for testing with the following tests: Scienetix PCR Respiratory Panel (RPP), Scienetix PCR Urinary Panel (UTI), Scienetix PCR Wound Panel and Scienetix PCR SARS-CoV-2 (COVID) since their implementation on 09/15/2023. Findings included: During the laboratory tour on 01/23/2024 at 10:00 AM, the surveyor found that there was no temperature gauge to monitor specimens arriving in the laboratory via courier at the accessioning area for BIOFIRE FILMARRAY Pneumonia panel, Scienetix PCR: RPP, UTI, Wound and COVID testing. 1-Review of BIOFIRE FILMARRAY Pneumonia Panel manufacturer instructions on page 13 under SAMPLE REQUIREMENTS, it stated on Transport and Storage: "Specimens should be tested with the BIOFIRE Pneumonia Panel as soon as possible. If storage is required, specimens can be held Refrigerated for up to 1 day (2-8C)." -Review of Policy number 22: Specimen Transportation. Implemented on 06/21/2021 and signed by the current Laboratory Director (LD) on 04/15/2022; it stated that samples need to be transported on ice and temperature monitored on reception. -Review of patients reports revealed the following: Patient #1 (collected on 02/18/2022), Patient #2, #3 and #4 (collected on 03/21/2022), Patient #5 and #6 (collected on 03/28/2022) were delivered via courier from Las Vegas. The laboratory failed to have documentation that monitored the temperature of the samples when they were received in the laboratory for testing with BIOFIRE FILMARRAY Pneumonia Panel. 2-Review of Policy number 44: Scienetix Q Tower UTI, RPP, ABR, Wound assay. Implemented on 09/15/2023 and signed by LD on 09/15/223, it stated on section "All Specimens ... the specimens should be transported in an environment that will not exceed room temperature". The policy failed to define the range for "room temperature". Review of "Policy number 24 Specimen Criteria and Rejection" implemented on 09/15/2023 revealed that on Section III "Procedure" it stated that " .... Urine, Respiratory, Sputum /Sputum-like, Buccal samples, Wound samples, and Fecal samples must arrive at room temperature or below." The policy failed to define the range for room temperature and failed to define how it will monitor the temperature of the samples on arrival. -The laboratory failed to have documentation that monitored the temperature of the samples delivered via courier. The laboratory tested the following number of samples since tests implementation on 09/15/2023: Scienetix PCR: RPP (156 samples), UTI (112 samples), Wound (7 samples) and COVID (1830 samples). During a telephone interview on 02/06/2024 at 09:30 AM, the laboratory manager confirmed that the laboratory failed to document the temperature of samples delivered to the laboratory during transportation and reception in the laboratory for BIOFIRE FILMARRAY Pneumonia Panel and for the Scienetix PCR: RPP, UTI, Wound and COVID. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial survey was completed on 3/29/2022 to 4/07/2022 at Pro Diametrics Corp dba Prodi Lab. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were not met: D 6076- Laboratory Director D 6134-Clinical Consultant 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 record review and interview, the laboratory failed to have a laboratory director (LD) that was licensed to oversee the bacteriology, virology and parasitology specialties from 2/15/2022 to present. (see 6078) 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 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 -- 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 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 record review and interview, the laboratory failed to have a laboratory director (LD) that was licensed to oversee the bacteriology, virology and parasitology specialties from 2/15/2022 to present. Findings included: Review of CMS-209 Laboratory Personnel Report revealed employee A was listed as the laboratory director and clinical consultant. Review of the LD personnel folder revealed the LD had a Doctor of Philosophy in Chemistry degree and State of Florida license as Clinical Laboratory Director in Clinical Chemistry. Review of the laboratory test menu displayed GI panel and Pneumonia panel tested with the Biofire listed as bacteriology, virology and parasitology. Review of Biofire validation for GI and Pneumonia panel revealed the LD had signed off on the validation as approved for use on 6/15/2021. During an interview on 3/29/2022 at 12:00 PM, the office manager stated that 2 patients were tested with the GI panel and 6 patients were test with pneumonia panel from 2/19/2022 to 3/28/2022. During an interview on 3/30/2022 at 2: 00 PM, the office manager confirmed the LD was unqualified to oversee the bacteriology, virology and parasitology areas. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review, the laboratory director was not quilified to perform a competency assessment for 1 out 1 testing personnel in the areas of bacteriology, virology and parasitology. Finding Included: Review of CMS-209 Laboratory Personnel Report revealed employee A was listed as the laboratory director and -- 2 of 3 -- Clinical Consultant. Employee B is listed as technical supervisor. Refer to 6078 - Based on record review and interview, the laboratory failed to have a laboratory director that was licensed to oversee the bacteriology, virology and parasitology specialties from 2/15/2022 to present. Review of Personnel Competency Assessments revealed the testing personnel competency assessment was done by the laboratory director for GI and pneumonia panel on the bio fire on 8/30/2021. During an interview on 3/30/2022 at 2:00 PM, the office manager confirmed the laboratory director was not quilified to perform a competency assessment for 1 out 1 testing personnel. 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 record review and interview, the laboratory failed to have a qualified clinical consultant (CC) in the laboratory for specialties of bacteriology, virology and parasitology from 2/15/2022 to present. (see D 6135) 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a qualified clinical consultant (CC) in the laboratory for bacteriology, virology and parasitology from 2/15 /2022 to present. Findings Included: Review of CMS-209 Laboratory Personnel Report revealed employee A was listed as the laboratory director and CC. Refer to 6078 - Based on record review and interview, the laboratory failed to have a laboratory director that was licensed to oversee the bacteriology, virology and parasitology specialties from 2/15/2022 to present. During an interview on 3/30/2022 at 2:01 PM, the office manager confirmed the CC was unqualified to oversee the bacteriology, virology and parasitology areas. -- 3 of 3 --