Grand Strand Pediatrics & Adolescent

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted at Grand Strand Pediatrics & Adolescent by South Carolina Department of Public Health (SC DPH) and Bureau of Nursing Homes and Medical Services on May 15, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR Part 493 Laboratory Requirements. The following is a list of CONDITION and STANDARD LEVEL deficiencies cited as a result of May 15, 2025, recertification survey. 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 records review and staff interview, the laboratory failed to enroll in a proficiency testing program approved by HHS for the specialties and subspecialities for which it seeks certification for 3 of 3 years reviewed (2023, 2024, and 2025). Findings included: 1. Review of records reveals the laboratory fail to enroll in a proficiency testing program for 3 of 3 years reviewed (2023, 2024 and 2025). 2. In an interview with testing personnel on May 15, 2025, at 2:44 pm in the office the above findings were confirmed. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to examine proficiency testing (PT) samples by personnel who routinely perform the testing in the laboratory for random events of the 3 years reviewed (2023, 2024 and 2025). Findings included: 1. Review of CMS 209 personnel report form reveals 7 testing personnel. 2. Review of PT records reveals 3 out of 7 testing personnel performed proficiency testing for 2 out of 3 years examined (2023, 2024 and 2025). a. FH1-A-2023 01-05- 2023 results 96% b. FH1-B-2023 06-10-2023 results 95% c. FH1-C-2023 11-15-2023 results 100% d. FH1-A-2024 01-05-2024 results 96% e. FH1-B-2024 06-10-2024 results 100% f. FH1-C-2024 11-15-2024 results 100% g. FH1-A-2025 01-05-2025 results 100% 3. In an interview on May 15, 2025, at 2:25 pm in the office with testing personnel the above findings were confirmed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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: Based on records reviewed and staff interview, the laboratory failed to ensure that the laboratory procedures and changes in procedures were approved, signed and dated by the current laboratory director before use. Findings included: 1. Documentation of the current laboratory director's approval for the use of the laboratory's standard operating procedures regarding all pre-analytic, analytic, and post-analytic phase of testing, quality assurance, quality control, patient test management, and personnel activities were unavailable to review on the day of the survey. 2. Testing personnel confirmed during an onsite interview on May 15, 2025, at 2:44 pm that the laboratory had failed to ensure the reviewed procedures were approved, signed and dated by the current laboratory director. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, lack of documentation and staff interview, the laboratory -- 2 of 4 -- failed to verify the accuracy of devices used to monitor temperature and humidity. The laboratory lacked evidence that the thermometer and timer were reliable to meet manufacturer's requirements. Findings included: 1. During a tour of the laboratory on May 15, 2025, at 1:46 pm, the surveyor observed AcuRite Indoor Digital Thermometer for temperature and humidity and a digital kitchen timer. 2. The surveyor requested but the laboratory failed to provide, verification of accuracy for the timer and thermometer used for waived and moderately complex testing. a. Henry Schein hCG Urine Cassette Test package inserts under storage and stability reveal temperature requirements "2-30 degrees C (36-86 degrees F)". Directions for use reveal timing requirements 3 minutes. b. Uricult CLED/EMB, Product No. 1000 package inserts reveal incubator thermometer to be calibrated to maintain a temperature of 97 +/-4 degrees F and Urine Culture-Paddles are to be stored at 45-to- 77-degree F(7 to 25 degrees C) before use. c. Occult Blood Test package insert reveals 30 seconds and 2-minute requirements for resulting test. d. Celly-Dyn Emerald hematology analyzer's operator manual on page 60 reveals "to ensure the instrument and reagents function properly, it is important to maintain the temperature between 64 -90 degrees F(18-32 degrees C)". 3. In an interview on May 15, 2025, at 2: 44 pm with testing personnel it was confirmed the thermometer, nor the timer were verified for accuracy. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, records review and staff interview, the laboratory failed to ensure reagents were used within expiration dates for moderately complex Complete Blood Cell Count (CBC) testing 3 of 3 vials viewed. Findings included: 1. A tour of the laboratory was conducted on May 15, 2025, at 1:46 pm, the surveyor observed 3 of 3 Cell-DYN 18 Plus Controls. a. High, Lot#5090, expire 07/18/2025 b. Normal, Lot#5090, expire 07/18/2025 c. Low, Lot#5090, expire 07/18/2025 No open or expiration date written on open vials. 2. Review of package insert reveals the vails are stable for 14 days after opened. 3. In an interview on May 15, 2025, at 1:46 pm in the laboratory with testing personnel the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on instrument operator manual review, lack of documentation and staff interview, the laboratory failed to document monthly maintenance on the Cell-Dyn hematology analyzer for thirty-four months reviewed from 2022 through 2025 (June 2022, July 2022, August 2022, September 2022, October 2022, November 2022, and December 2022). Findings include: 1. Review of the Cell-Dyn hematology analyzer operator's manual reveals that all operators should routinely perform scheduled -- 3 of 4 -- maintenance to ensure optimum performance of the instrument including a monthly cleaning and monthly clot prevention. 2. Review of records revealed the laboratory lack sufficient documentation of monthly maintenance had not been documented for thirty-four months reviewed from 2022 through 2025. 3. In an interview with testing personnel on May 15, 2025, at 2:44 pm in the office that the monthly maintenance had been written on a calendar, no other documentation was available for the months reviewed. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review conducted on 03/03/22, review of the Centers for Medicare and Medicaid (CMS) 155D CASPER report, and College of American Pathologists (CAP) results, it was determined that the laboratory failed to successfully participate in proficiency testing for the the analytes, red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb), for three out of five consecutive proficiency testing events reviewed (2020, Events 1 and 3 and 2021, Event 2). (see D2130) D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review conducted on 03/03/22, review of the Centers for Medicare and Medicaid (CMS) 155D CASPER report, and College of American Pathologists (CAP) results, it was determined that the laboratory failed to successfully participate in proficiency testing for the analyte(s) red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb), for three out of five consecutive proficiency testing events reviewed (2020, Events 1 and 3 and 2021, Event 2). D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review conducted on 03/03/22, review of the Centers for Medicare and Medicaid (CMS) 155D CASPER report, and College of American Pathologists (CAP) results, it was determined that the laboratory director failed to ensure proficiency testing for the analyte(s), red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb) was performed as required by 42 CFR, Part 493.801 (see D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review conducted on 03/03/22, review of the Centers for Medicare and Medicaid (CMS) 155D CASPER report, and College of American Pathologists (CAP) results, it was determined the laboratory director failed to ensure the laboratory attained a result of 80% for the analytes red blood cell (RBC), hematocrit (Hct), and hemoglobin (Hgb), for three out of five consecutive proficiency testing events reviewed (2020, Events 1 and 3 and 2021, Event 2). (see D2130) -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a PT desk review performed on 03/11/2021, based on review of CASPER report 155D and graded reports from College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the following regulated hematology anlytes: Cell ID, red blood cell (RBC), hematocrit (HCT), hemoglobin (Hgb), white blood cell (WBC), and platelets (Plt) for two of three consecutive proficiency testing events reviewed (2020, Events 1 and 3). See D2121 and D2130. D2121 HEMATOLOGY 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 -- CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During a proficiency testing desk review performed on 03/11/2021, based on review of the CASPER report 155D and laboratory proficiency testing records (graded report from CAP), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the specialty of hematology, the analytes Cell ID, RBC, HCT, HGB, WBC, Plt for two consecutive proficiency testing events (2020, Events 1 and 3). The findings include: 1. Review of CASPER report 155D revealed the following Plt proficiency scores for your laboratory for 2020 Event 1: a. CELL ID: 0% b. RBC: 0% c. HCT: 0% d. HGB: 0% e. WBC: 0% f. Plt: 0% Review of CASPER report 155D revealed the following Plt proficiency scores for your laboratory for 2020 Event 3: a. CELL ID: 0% b. RBC: 0% c. HCT: 0% d. HGB: 0% e. WBC: 0% f. Plt: 0% 2. The scores were confirmed upon review of the graded CAP reports. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: During the desk review performed on 03/11/2021, based on review of CASPER report 155D and graded CAP results, it was determined that the laboratory failed to achieve satisfactory performance for the analyte Cell ID, RBC, HCT, HGB, WBC, and Plt in two of three consecutive testing events (2020, Events 1 and 3) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --