Ada Pediatrics Pa

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of microbiology media records and an interview with the office manager on 4/15/2022, the laboratory failed to check each lot of prepared plated medium for its ability to support growth and/or inhibit growth prior to reporting urine colony count results. The findings include: 1. A review of microbiology media records identified that the laboratory failed to perform and document quality control (QC) to show the ability of the Hardy Blood Agar/MacConkey Biplate to support growth for lot numbers 499553, 492447, 487839, 481005, 475333 and 47329 prior to releasing patient urine colony count results. 2. A review of microbiology media records identified that the laboratory failed to perform and document QC to show the ability of the MacConkey portion of the Hardy Biplate to inhibit growth for lot numbers 499553, 492447, 487839, 481005, 475333 and 47329 prior to releasing patient urine colony count results. 3. An interview with the office manager on 4/15/2022 at 10:03 am confirmed that the laboratory failed to perform QC on media before patient results were reported. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 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 -- 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. This CONDITION is not met as evidenced by: Based on record review of the CMS-209 Personnel Report Form, personnel education documents and an interview with the office manager on 4/15/2022, the laboratory failed to have a qualified technical consultant (TC) that meets the educational requirements listed in the state operations manual subpart M. See 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 record review of the CMS-209 Personnel Report Form, personnel education documents and an interview with the office manager on 4/15/2022, the laboratory failed to ensure that the employee listed as the technical consultant (TC) met one of the educational requirements listed in the state operations manual subpart M to qualify as technical consultant. The findings include: 1. A review of the CMS-209 and -- 2 of 3 -- personnel education documents for the employee listed as the TC and fulfilling the TC responsibilities identified that the laboratory failed to have documentation of at least a Bachelor's degree in chemical, physical or biological science for the employee. 2 An interview with the office manager on 4/25/ 2022 at 9:21 am, confirmed that the laboratory failed to have a qualified TC. -- 3 of 3 --

Summary Statement of Deficiencies 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 personnel training and competency assessment records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and an interview with the Technical Consultant (TC), the laboratory failed to follow written policies and procedures to assess competency of testing personal at the 6 month interval. The findings include: 1. The CMS-209 form identifies seven (7) testing personnel who perform waived and moderate complexity testing. Two (2) of the seven (7) testing personal did not have documentation of 6 month competency assessment following their initial training. 2. An interview with the TC on 11/19/20 at 1:30 PM confirmed that there was not documentation for 6 month competency assessment for two (2) of the seven (7) listed testing personnel. 3. The laboratory reports performing 1,500 waived and 22 non-waived patient specimens annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review of the laboratory's policy and procedure manual and an interview with the Technical Consultant (TC), the laboratory director failed to 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 -- approve, sign, and date the laboratory's policies and procedures as well as any changes in procedures. The findings include: 1. The laboratory director failed to approve, sign, and date all procedures in the laboratory's policy and procedure manual. 2. The laboratory director failed to approve, sign, and date the following procedures that had a revision date of May 21, 2020: "Protocol for Documenting Results," "Procedure for Lead Screening and Reporting," "Procedure for Collecting Blood Sample for HgB," "Procedure for Conducting a Streptococcus Test," "Procedure for Collecting a Clean Catch Urine," and "Urine Colony Count." 3. An interview with the TC confirmed the above findings on 11/19/20 at 1:45 PM 4. The laboratory reports performing 1,500 waived and 22 non-waived patient specimens annually D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an observation of the laboratory's incubator, record review of incubator temperature logs, and interview with the Technical Consultant (TC), the laboratory failed to perform and document periodic calibration checks of the thermometer in use in the incubator for urine colony counts. The findings include: 1. A direct observation of one (1) glass thermometer in use in the incubator for urine colony counts, had no documentation or record of periodic calibration. 2. A review of the incubator temperature log sheets revealed that there was no documentation of periodic thermometer calibration from the last survey on 05/11/18 to the current survey date of 11/19/20. 3. An interview with the TC on 11/19/20 at 2:30 PM confirmed that there was no documentation of calibration of the glass thermometer in use in the incubator for urine colony counts. 4. The laboratory reports performing 22 urine colony counts annually. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to attain satisfactory performance in bacteriology for the Medical Laboratory Evaluation (MLE) 2018 event 1. Findings: 1. An MLE PT review for bacteriology revealed the laboratory scored a 60% for the 2018 testing event 1. 2. An interview on May 11, 2018 at 1:30 PM, with the laboratory manager, confirmed the laboratory failed to achieve satisfactory performance in bacteriology. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on personnel record reviews and an interview with the laboratory manager, the laboratory failed to evaluate the competency of the testing personnel performing urine colony counts in 2017. Findings: 1. A record review of personnel records revealed the laboratory failed to document the competency of ten testing personnel listed on the 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 -- CMS-209 Personnel Report form during 2017. 2. An interview on May 11, 2018 at 1: 15 PM, with the laboratory manager, confirmed the laboratory failed to document competency assessments on the testing personnel. -- 2 of 2 --