Anderson Hills Pediatrics Inc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interviews with Testing Personnel (TP) #4 and TP #11, the laboratory failed to enroll in a proficiency testing (PT) program for the sub- specialty of Bacteriology. This deficient practice had the potential to affect 461 out of 461 patients tested in the subspecialty of bacteriology from 08/17/2023 through 07/22 /2025. Findings Include: 1. The laboratory failed to enroll in a proficiency testing (PT) program for Bacteriology specimens. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; and 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 -- This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #4 and TP #11, the laboratory failed to enroll in a proficiency testing (PT) program which contained five test specimens per event for moderate complexity urinalysis. This deficient practice had the potential to affect 461 out of 461 urinalysis tests under the subspecialty of Bacteriology from 06/17/2023 through 07/22/2025. Findings Include: 1. Review of the urinalysis procedure titled "Proficiency Testing Guidelines" signed and dated by the Laboratory Director on 08/31/2022, found the following statement: "Urine Colony Count - three times per year in March, June, October" 2. Further review of the urinalysis proceure did not find any mention of the number of challenges per event for PT. 3. The inspector reviewed the urine colony count American Proficiency Institute PT results from the 2023 third event through the 2025 second event which revealed the following: Year Event Test Samples 2023 Third Event UR-11, UR-12 2024 First Event UR-01, UR-02 2024 Second Event UR-06, UR- 07 2024 Third Event UR-11, UR-12 2025 First Event UR-01, UR-02 2025 Second Event UR-06, UR-07 4. The inspector requested urine colony count PT results for the 2023 third event through the 2025 second event which included five test specimens from TP #4 and TP #11. TP #4 and TP #11 confirmed the laboratory only completed PT which included two test specimens per event and were unable to provide the requested documentation on the date of the inspection. The interview occurred on 07 /22/2025 at 11:30 AM. -- 2 of 2 --

Summary Statement of Deficiencies 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 document review, direct observation and an interview with Testing Personnel (TP#12), laboratory personnel failed to follow the written procedure manual for specimen processing with one out of one specimens. This deficient practice had the potential to affect all patients tested under the subspecialty of bacteriology on 09/17/2019. Findings include: 1. Review of the laboratory policy titled "Anderson Hills Pediatrics Quality Assurance", approved by the Laboratory Director 05/12/2014 found the following statement: "...All specimens must be properly identified when they are collected with the patient name and chart number." 2. Direct observation of the laboratory on 09/17/2019 at 11:34 AM found one urine specimen cup labeled with only the patient's first name. The urine specimen cup indicated above lacked the patient's full name and chart number as required per the laboratory's protocol. 3. TP #12 confirmed the urine specimen cup had been labeled incorrectly. The interview occurred on 09/17/2019 at 11:35 AM. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. 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 -- This STANDARD is not met as evidenced by: Based on review of the Illumegene instrument printouts and interviews with the Laboratory Director (LD) and Testing Personnel (TP#12), the laboratory failed to retain group Streptococcus A (Strep A), instrument printouts. This deficient practice had the potential to affect all patients tested under the subspecialty of bacteriology. Findings Include: 1. The surveyor requested the laboratory's Illumigene analyzer instrument printouts for patient testing for 2018 through 2019 from TP#12. TP#12 provided one instrument printout dated 09/16/2019 time stamped 2:58 PM. 2. TP#12 and the LD stated the laboratory throws away the Illumigene patient test printouts after the data has been transcribed into the electronic medical record and could not provide the requested documents. The interviews occurred on 09/17/2019 at 11:00 AM. -- 2 of 2 --