All Care Pediatrics, Pa

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 surveyor review of the Competency Assessment (CA) records and interview with the Office Manager (OM) the laboratory failed to follow its policies and procedures for assessing the competency of Testing Personnel who perform Bacteriology testing in the calendar year 2020. The findings include: 1. The CA was not performed twelve out of twelve TP in 2020. 2. The TP #8 listed on CMS form 209 confirmed on 12/2/2021 at 1:30 pm that the CA was not performed. 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 surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each batch of Selective Strep 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 -- Agar (SSA) used for Throat Culture (TC) tests for sterility, its ability to support growth and select or inhibit specific organisms from 10/6/21 to the date of the survey. The findings include: 1. Current lots of SSA in use #128026/1746 and 141097 did not have documented evidence QC was performed prior to putting into use. 2. The laboratory performed approximately 448 TC per month. 3. The TP #8 listed on CMS form 209 confirmed on 12/2/21 at 2:00 pm that the laboratory did not perform QC as stated above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Test Personnel (TP), the Laboratory Director (LD) failed to have appropriate education documentation for all Testing Personnel (TP) performing laboratory testing from 6/6 /19 to the date of survey. The findings include: 1. The laboratory did not have education records for three out of twelve TP listed on the CMS form 209. 2. The TP #8 on CMS form 209 confirmed on 12/2/21 at 1:40 pm the above records were not on file. -- 2 of 2 --

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 the surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of culture media for sterility, ability to support growth and select or inhibit organisms from 5/15/19 to the date of the survey. The finding Includes: 1) Selective Strep Agar plates Lot # 1907707 was not checked for sterility, ability to support growth and ability to select or inhibit organisms. 2) Approximately 10 patients were runs and reported each day of testing. 3) The TP #1 list on CMS form 209 confirmed on 6/6/2019 the laboratory did not perform the above QC. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically 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 -- transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of Patient Charts (PC), work records, and interview with the Testing Personnel (TP), the laboratory failed to ensure test results were transcribed for Urine Culture (UC) test from 11/10/18 to the date of survey. The finding includes: 1. One out of five patients test results was not entered in the PC. 2. The TP #1 listed on CMS from 209 confirmed on 6/6/19 at 10:00 am that the laboratory did not transcribe results in the PC. -- 2 of 2 --