Grand Strand Pediatrics & Adolescent

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted at Grand Strand Pediatrics and Adolescent Medicine on October 22, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR 493. CLIA Laboratory Requirements. The following is a list of STANDARD Level deficiencies cited as a result of the CLIA recertification survey on October 22, 2025. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 lack of documentation, annual test volume, and staff interview, the laboratory failed to establish, approve and follow a written procedure for moderately complex test for Complete Blood Cell Count (CBC) and urine culture(s) before testing patient samples. Findings include: 1. A written and approved procedure for CBC testing was unavailable to review on the day of the survey. 2. A written and approved procedure for urine culture test was unavailable to review on the day of the survey. 3. The laboratory listed an annual volume of 615 CBCs on the CMS 116 form. 4. The laboratory listed an annual volume of 165 bacteriology tests on the CMS 116 form. 5. During an interview on October 22, 2025, at 10:55 am with nurse manager and assistant nurse manager in the office, confirmed that the laboratory failed to establish, approve and follow written procedures for CBCs and urine cultures. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 -- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory director failed to ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. Findings included: 1. A review of CMS 116 revealed the Cell Dyn Emerald is used for testing CBCs. 2. A review of CMS 116 reveals the Aidian urine paddle system is being used for bacteria colony counts. 3. Review of laboratory documentation reveals the lack of written policies and procedures for the following: a. Step by Step procedure of how to run the Cell Dyn Emerald analyzer to result CBCs. b. Step by Step procedure of how-to setup and result a urine culture with the Aidian uricult paddle system. 4. During an interview on October 22, 2025, at 10:55 am with nurse manager and assistant nurse manager in the office, confirmed that the laboratory failed to establish, approve and follow written procedures for CBCs and urine cultures. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: During an onsite recertification on 12/12/2019, based on lack of documentation and testing personnel interview, the laboratory failed to verifiy the accuracy of Uricult testing at least twice annually for 2 of 2 years reviewed (2018, 2019). Findings include: 1. Documentation of a semi-annual test accuracy verification for the Uricult testing for 2018 and 2019 was unavailable for review on the the day of the survey . 2. Testing personnel confirmed during an onsite interview on 12/12/2019 at 2:00pm that the laboratory had failed to verify accuracy of Uricult testing at least twice annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a policy and procedure manual review, lab record review and testing personnel interview, it was determined that the lab failed to document acceptable 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 -- room and humidity temperature readings for 9 of 24 months reviewed from January 2018 through December 2019 (2018: July, August, September, October, November, December; 2019: January, February, and April) Findings include: 1. A review of the laboratory policy and procedure manual on 12/12/19 revealed that the laboratory room temperature should operate between 68 to 90 degrees Fahrenheit and humidity should operate between 10 to 90 percent. 2. A review of the lab room temperature log on 12 /12/19 revealed that the lab's room temperatures were below 68 degrees Fahrenheit for the following months: a. January 2019: 1 day b. February 2019: 4 days c. April 2019: 1 day d. July 2018: 28 days e. August 2018: 31 days f. September 2018: 30 days g. October 2018: 31 days h. November 2018: 30 days i. December 2018: 31 days Humidity was not documented for the following months: a. July 2018: 28 days b. August 2018: 31 days c. September 2018: 30 days d. October 2018: 31 days e. November 2018: 30 days f. December 2018: 31 day 3. During an onsite interview at 2: 00 pm, testing personnel confirmed that the laboratory had failed to document acceptable room and humidity temperature readings for 9 of 24 months reviewed from January 2018 through December 2019 (2018: July, August, September, October, November, December; 2019: January, February, and April). 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: During an onsite recertification survey on 12/12/2019, based on patient test log review, lack of documentation and testing personnel interview, the laboratory failed to perform quality control checks on each batch of Uricult CLED/EMB agar received prior to patient testing. Findings include: 1. Review of the laboratory's patient test log revealed thatcUricult CLED/EMB testing was routinely performed and reported in the laboratory from July 2017 to the day of the survey. 2. Documentation of quality control checks on each batch of Uricult CLED/EMB agar for its ability to support growth or produce a biochemical response prior to reporting patient results was not available for review on the day of the survey. 3. Testing personnel confirmed during an onsite interview on 12/12/19 at 2:30pm that the laboratory had failed to perform quality control procedures as required. -- 2 of 2 --