Prc Associates Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on February 11, 2020. PRC Associates LLC is NOT in compliance with 42 CFR, Part 493 Requirements for Laboratories. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory had not tested chemistry proficiency testing samples the same number of times that it tests patient samples for two of four American Proficiency Institute (API) testing events reviewed. Findings included: A record review of 2018 and 2019 API Chemistry proficiency testing (PT) was conducted on February 11, 2020. The analytes tested are: Creatinine, pH, Amphetamines, Barbiturates, Benzodiazepine, Cannabinoids, Cocaine Metabolites, MDMA (3,4-Methylenedioxymethamphetamine), Methadone, Opiates, Oxycodone, Phencyclidine, and Alcohol. The first event of 2018 showed the samples UDS01, UDS02, UDS03, UAD01, UAD02, and UAD03 were tested on 4/24/2018 and 4/26 /2018. The API "Submitted Results Form" showed the results were submitted electronically on 5/1/2018. The review of the second event in 2019 showed the samples UDS04, UDS05, UDS06, UAD04, UAD05, and UAD06 were tested on 10/16 /2019, 10/17/2019, and 10/22/2019. The API "Submitted Results Form" showed the results were submitted electronically on Oct 22, 2019. Review of the policy titled "Proficiency Testing" states "Proficiency test samples must be tested the same number of times that patient samples are routinely tested. The laboratory must use the same procedures for both patient samples and PT samples. Do not run PT samples multiple times if patient samples for that testing are not routinely run multiple times". The interview with the Technical Supervisor on 2/11/20 at 11:30am confirmed the PT samples were run multiple times. 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 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of records and interview, the laboratory failed to follow their procedures to document annual competency evaluations for one of one Testing Persons on staff for two of two years reviewed (2018-2019). Findings include: At the time of survey, the Technical Supervisor was unable to provide documentation of Competency Assessment for 2018 and 2019. The facility policy titled "Competency" states "New personnel as assessed initially during training, at 6 months, and at least annually thereafter by the Laboratory Director or designee". The interview with the Technical Supervisor on 2/11/20 at 11:30am confirmed the competency assessments had not been completed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director failed to ensure testing personnel were competent and that competency was maintained. Findings include: The Laboratory Director failed to ensure all testing personnel that perform moderate complexity testing had competency evaluations in 2018 and 2019. (See D5209) D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on record review and staff interview, the Laboratory Director failed to ensure testing personnel were competent and that competency was maintained. Findings include: The Laboratory Director failed to ensure all testing personnel that perform high complexity testing had competency evaluations in 2018 and 2019. (See D5209) -- 3 of 3 --

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 record review and interview with the Technical Supervisor, the laboratory failed to have an acting Laboratory Director. Findings Included: 1. The laboratory did not have a Laboratory Director (See 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 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 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 -- 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 with the Technical Supervisor, the laboratory failed to have an acting Laboratory Director. The findings include: Review of the policy and procedure manual showed it was last signed and dated 9/28/2017 by the retired Laboratory Director. There was no delegation of duties signed by the Laboratory Director to give anyone else responsibilities of the Laboratory Director. During an interview on 2/19/18 at 10:45am, the Technical Supervisor confirmed that the Laboratory Director on record retired at the end of December 2017. It was confirmed that the Florida Agency for Healthcare Administration was notified of the Laboratory Director change on 1/4/18. The agency sent a letter to the physician dated 1 /9/18 requesting more information and required a response by 1/30/18. No response has been received by the physician as of the date of survey. -- 2 of 2 --