Summary:
Summary Statement of Deficiencies D0000 Based on an on-site initial certification survey conducted on February 27, 2025, deficiencies were cited for Altitude Dermatology, PC in Johnstown, Colorado. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, and an interview with the Mohs tech (not included on CMS-209 form), the laboratory failed to establish a written policy or procedure for a quality assurance (QA) plan, establishing an ongoing mechanism to monitor, assess and correct problems when indicated concerning: patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing performance since the laboratory began patient testing in July of 2024. Findings include: 1. A review of the laboratory's policies and procedures manual revealed the laboratory failed to have a written policy or procedure for a QA plan, establishing an ongoing mechanism to monitor, assess and correct problems when indicated concerning: patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing performance. 2. Based on an interview with the Mohs tech (not included on CMS-209 form) on February 27, 2025, at approximately 09:00 AM, confirmed that the laboratory failed to have a written policy or procedure for a QA plan establishing an ongoing mechanism to monitor, assess and correct problems when indicated 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 -- concerning: patient confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing performance. 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 a review of the laboratory's policies and procedures manual, and an interview with the Mohs tech (not included on CMS-209 form), the laboratory failed to ensure that the laboratory director (LD) had approved, signed and dated all the laboratory's policies and procedures prior to their use in the laboratory since the laboratory began patient testing in July of 2024. Findings include: 1. A review of the laboratory's policies and procedures manual revealed the laboratory's policies and procedures manual was not signed or dated by the LD. 2. An interview with the Mohs tech (not included on CMS-209 form), on February 27, 2025, at approximately 09:05 AM confirmed that the laboratory's policies and procedures manual had not signed or dated by the LD. -- 2 of 2 --