Summary:
Summary Statement of Deficiencies D0000 An onsite initial survey was conducted at Coastal Carolina Behavioral Health on May 16, 2025 by South Carolina Department of Public Health (SC DPH). The facility was found to be out of compliance with the Medicare Condition at 42 CFR part 493 CLIA Laboratory Requirements. The following is a list of CONDITION Level deficiencies cited as a result of the CLIA INITIAL survey on May 16, 2025. 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. Findings include: 1. Review of records reveals the laboratory failed to enroll in a proficiency testing program for 2 of 3 years reviewed (2023, 2024, and 2025). 2. In an interview with laboratory director (LD) on May 16, 2025, at 2:02 pm in the office the above findings were confirmed. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. Review of policies and procedures reveals a lack of establish written policy for how the laboratory will document all quality assessment activities pre-analytical, analytical and post-analytical, when necessary what