Pediatricare Associates

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 surveyor review of Quality Control (QC) records and interview with the Teting Personnel (TP), the laboratory failed to check each batch of Selective Strep Agar (SSA) used for Throat Culture (TC) tests for sterility, its ability to support growth, select or inhibit specific organisms and document the physical characteristics of the media from 6/21/23 to the date of the survey. The findings include: 1. There was no documented evidence the above mentioned QC was performed on SSA lot # 601915. 2. The TC confirmed on 7/19/23 at 11:00 am 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 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 -- 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 Testing Personnel (TP), the Laboratory Director (LD) failed to have appropriate education documentation on all Testing Personnel (TP) performing laboratory testing on the date of survey. The findings include: 1. The laboratory did not have education records for two out of ten TP listed on the CMS form 209. 2. The TP confirmed on 7/19/23 at 10: 40 am the above records were not on file. -- 2 of 2 --

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 Nurse Manager (NM), the laboratory failed to perform the CA for Testing Personnel (TP) in 2019 and 2020. The finding includes: 1. Eleven out of eleven TP did not have a CA performed in the calendar year 2019 or 2020. 2. The NM confirmed on 6/10/2021 at 10:00 am that CA was not performed D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Bacitracin Disk Quality Control Log (QC) and interview with the Nurse Manager (NM), the laboratory failed to follow the PM for Control Procedures from 11/19/18 to the date of the survey. The findings include: 1. The QC log shows "QZ Organism used Lot # Health line". 2. 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 -- There was no documented evidence showing that lot numbers and expiration dates were recorded. 3. The NM confirmed on 6/10/21 at 10:45 am that the laboratory did not follow the PM. 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 Nurse Manager (NM), the laboratory failed to check each new lot number and shipment of Throat Culture media for sterility from 11/19/18 to the date of the survey. The NM confirmed on 6/10/21 at 10:30 am the laboratory did not perform the above QC. -- 2 of 2 --

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 the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on 12 of 12 TP from 12/1/16 to the date of survey. The finding includes: 1. The CA did not include how assessment was done and what records were reviewed. 2. The CA did not include which test was assessed. 3. The TP # 1 listed on CMS form 209 confirmed on 11/19 /18 at 12:25 pm that CA was not done correctly. 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 surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to perform Competency Assessment (CA) responsibility from 12/1/16 to the date of survey. The findings include: 1. The CA was not performed by TC. 2. The TP # 1 performed CA on 12 ot 12 TP but was not qualified to perform CA. 3. The TP # 1 listed on CMS form 209 confirmed on 11/19/18 at 12:15 pm that the CA was not performed by TC. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --