Summary:
Summary Statement of Deficiencies D0000 A Certification survey was performed on January 26, 2024 at Cenla Dermatology, CLIA ID # 19D2100442. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have a system for handling complaints and problems reported to the laboratory. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written instructions for the investigation of complaints. 2. In interview on January 26, 2024 at 10:35 am, the laboratory staff confirmed the laboratory did not have a written procedure for reporting/handling complaints. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with 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 -- personnel, the laboratory failed to have a system in place to ensure that the documentation of communication problems are reported to the laboratory. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written instructions to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. In in interview on January 26, 2024 at 10:35 am, the laboratory staff confirmed the laboratory did not have a communication policy in place. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to have a system for handling complaints and problems reported to the laboratory. Refer to D5205. 2. The laboratory failed to have a system in place to ensure that the documentation of communication problems are reported to the laboratory. Refer to D5207. -- 2 of 2 --