Annapolis Pediatrics - Edgewater

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the director of clinical services, the laboratory failed to ensure that the individual testing or examining the PT samples signed the PT attestation statements, attesting that PT specimens were run in the same manner as patient samples. Findings: 1. A review of microbiology PT records from 2022 through 2023 showed that in three out of four events, the names of the five different testing personnel (TP) written on the attestation statements were all written in the same handwriting. 2. The attestation statement must be signed by the TP who actually performs the PT. 3. During an interview on 02/29 /2024 at 11:30 AM, the director of clinical services confirmed that the TP performing the PT did not sign their own names to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 --

Summary Statement of Deficiencies D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the laboratory supervisor (LS), the laboratory director failed to ensure that the laboratory was enrolled in a PT program that met the criteria of subpart I for testing in the specialty of bacteriology. Findings: 1. The laboratory performed throat cultures to screen for the presence of group A streptococcus bacteria which is a regulated test in subpart I in the code of federal regulations (CFR) found at 42 CFR 493.911. 2. The laboratory performed urine colony counts which is an unregulated test as it is not listed in subpart I. 3. The requirements in subpart I for bacteriology regulated testing is to test "a minimum of five samples per testing event" with "at least three testing events at approximately equal intervals per year." 4. The laboratory was enrolled in a PT program that included three testing events per year but evaluated two PT samples for group A streptococcus antigen, which is a waived test, two PT samples for urine colony count, which is an unregulated test, and two PT samples for throat culture, which is a regulated test. 5. The laboratory was not enrolled in a PT program that tested a minimum of five throat culture PT samples three times per year. 6. During the survey on 09/01/2022 at 12:45 PM, the LS confirmed that the laboratory was not enrolled in a PT program that included five samples per PT event for throat culture screening for group A streptococcus which is a regulated test. 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 --

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 standard operating procedure manual (SOPM) and laboratory patient log review and interview with the technical consultant (TC), the laboratory did not follow written procedures for performing bacteriology testing. Findings: 1. The laboratory performs bacteriology testing on throat swabs for Group A streptococci. A review of the procedure, "Strep Cultures" shows that testing personnel are to interpret the growth on the plate at "18-24 hrs." 2. A review of "Strep A-Rapid/Culture Patient Logs" from January, 2018 to December, 2019 showed that testing personnel also perform a "48HR READ" on throat culture plates before reporting the test results. 3. During an interview on 1/29/20 at 11:45 AM, the TC confirmed that the written SOPM did not accurately reflect the actual practice of the laboratory. 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: I. Based on standard operating procedure manual (SOPM) review and interview with the technical consultant (TC), the laboratory did not ensure that the SOPM was signed 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 -- and dated by the laboratory director (LD). Findings: 1. The laboratory changed directors on 1/1/20. A review of the current SOPM showed that the procedures were not approved (signed and dated) by the current LD. 2. During an interview on 1/29/20 at 11:45 AM, the TC confirmed that the SOPM was not signed and dated by the new LD. II. Based on standard operating procedure manual (SOPM) review and interview with the technical consultant (TC), the laboratory did not ensure that the SOPM was updated when changes to the laboratory occurred. Findings: 1. The laboratory discontinued use of their hematology instrument on 1/15/18. A review of the SOPM showed that the procedure, "Review of Daily Quality Control Results" included a section on "Daily Review for CBC analysis." 2. During an interview on 1/29/20 at 11: 45 AM, the TC confirmed that the SOPM was not updated and approved by the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that a copy of all PT documents were maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of PT records from 2016 to 2017 showed that the attestation statement for event 3, 2017 in hematology was not present at the time of the survey. 2. During an interview on 2/1/18 at 11:30 AM, the TC confirmed that the attestation statement was missing for the above listed PT event. D5781