Steeplechase Pediatric Center Pa

Summary Statement of Deficiencies D0000 An announced VALIDATION survey of the laboratory was conducted on 02/29/2024. The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. 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 review of laboratory's policies/procedures, personnel competency assessment records and staff interview, the laboratory failed to document competency assessment for one of one Technical Consultant employed by the laboratory in 2022 and 2023. Findings included: 1. Review of laboratory's policy "General Laboratory Quality Assurance" (adopted 07/07/2008, last reviewed 04/01/2021) revealed: "... all employees are evaluated on an annual basis." There were no other policies addressing personnel competency assessment available for review. 2. Review of laboratory's personnel competency assessment records for 2022 and 2023 revealed the person performing the duties of technical consultant did not have documentation of Technical Consultant Competency Assessment for either 2022 or 2023. 3. In an interview on 02 /29/2024 at 0930 hours in the patient examination room, the facility's Technical Consultant (as indicated on submitted Form CMS 209) confirmed the findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer instructions, laboratory's policies/procedures, quality control (QC) records, patient test records and staff interview, the laboratory failed to document required quality control for 2 of 181 days reviewed in 2023. Findings included: 1. Review of manufacturer's instructions "Medonic M-series User's Manual" (document Art no 1504472) revealed: "...Medonic M-Series system is checked daily with certified blood controls..." 2. Review of laboratory's policy "General Laboratory Quality Assurance" (last reviewed 04/01/2021) revealed: "Normal and abnormal controls should be assayed daily, or with each batch of test run, (as recommended by the manufacturer), ..." 3. Review of laboratory's QC records from January through June 2023 revealed the laboratory tested 3 levels of control each day of patient testing, but there was no documentation of QC testing for the following 2 of 181 days reviewed: 02/27/2023 02/28/2023 4. Review of patient test records for the above days revealed the following patients were tested with no documentation of QC tested: Date: 02/27/2023 Patient tested: 201576 Date: 02/28/2023 Patient tested: 195881 5. In an interview on 02/29/2024 at 1120 hours in the patient examination room, the facility's Technical Consultant (as indicated on submitted Form CMS 209), stated that the QC was most likely performed, but the QC records for those 2 days could not be located. This confirmed the findings. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on review of laboratory's submitted form CMS 209, personnel records and staff interview, the Laboratory Director failed to ensure one of one personnel performing Technical Consultant duties in 2022 and 2023 had the required education for the position. Refer to D6035. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on review of laboratory's personnel records and staff interview, the laboratory failed to have one of one technical consultant who meet qualification requirements for that position. Findings included: 1. Laboratory failed to ensure its Technical Consultant met the educational requirements to qualify for the position. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant 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)(i) Be a doctor of medicine, 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)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of laboratory's submitted form CMS 209, personnel records and staff interview, the laboratory failed to ensure one of one personnel performing Technical Consultant (TC) duties in 2022 and 2023 had the required education for the position. Findings included: 1. Review of laboratory's submitted form CMS 116 revealed the laboratory employed one Technical Consultant. 2. Review of laboratory's personnel records revealed the laboratory's Technical Consultant did not have documentation of education necessary to qualify for the position. The only documentation available for review was a transcript of uncompleted associate degree from Lone Star College. 3. In -- 3 of 4 -- an interview on 02/29/2023 at 0920 hours in the patient examination room, the facility's Technical Consultant (as indicated on submitted form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 4 of 4 --