Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed on June 24, 2024 through June 27, 2024 at Pointe Coupee, CLIA ID # 19D0462236. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with laboratory personnel, the laboratory failed to establish a complete written competency assessment policy for Technical Consultant and General Supervisor. Findings: 1. Review of the laboratory's "Competency Testing" policy revealed the laboratory did not include performance of competency assessment for Technical Consultant and General Supervisor. 2. In interview on June 24, 2024 at 3:15 p.m., the Laboratory Manager confirmed the laboratory did not have a policy for assessing the competency of the Technical Consultant and General Supervisor. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to ensure policies and procedures were updated to current practices and signed by the current Laboratory Director. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) Current Method Validation procedure; laboratory had three (3) different procedures b) Proficiency Testing policy: approved/signed by the current Laboratory Director c) Competency Assessment policy: approved/signed by the current Laboratory Director d) Patient Grievance policy: approved/signed by the current Laboratory Director e) Hematology procedures: approved/signed by the current Laboratory Director 2. In interview on June 26, 2024 at 9:05 am, the Laboratory Manager stated she is in the process of updating the laboratory's policies and procedures. The Laboratory Manager confirmed the Laboratory Director had not approved all of the laboratory's policies and procedures. 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: I. Based on observation by surveyors, review of manufacturers' storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of the hallway area where mobile phlebotomy carts were stored. Findings: 1. Observation by surveyors during laboratory tour on June 24, 2024 at 1:23 pm revealed the laboratory stored the following laboratory supplies on mobile phlebotomy carts in a hallway area near a door without monitoring the room temperature: a) FLOQ swabs b) Copan UTM -RT transport medium c) Vacuette blood transfer unit d) BD Vacutainer sodium fluoride blood collection tubes e) Vacuette serum blood collection tubes f) Vacuette lithium heparin blood collection tubes g) Vacuette K2EDTA blood collection tubes h) Remel Microtest M4RT tubes 2. Review of the manufacturers' storage requirements revealed the following: a) FLOQ swabs: 2-30 degrees Celsius b) Copan UTM-RT transport medium: 2-25 degrees Celsius c) Vacuette supplies: 4-25 degrees Celsius d) BD Vacutainer: 4-25 degrees Celsius e) Remel tubes: 2-30 degrees Celsius 3. In interview on June 24, 2024 at 2:02 pm, the Assistant Lab Manager confirmed the laboratory did not monitor the room temperature of the area where the mobile phlebotomy carts were stored. 47757 II. Based on observation, review of the laboratory's temperature records and manufacturers' instructions for use, and interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturers' required ranges for one (1) of eight (8) areas where laboratory supplies are stored. Findings: 1. Observation by surveyors during the laboratory tour on June 24, 2024 at 1:22 p.m. revealed the laboratory stored the following laboratory supplies in the "Urinalysis" room: a) BD Vacutainer C&S Preservative - Manufacturer's storage requirement 4 - 25 degrees Celsius b) Remel Saline (0.85%) 1 ml - Manufacturer's storage requirement 2 - 25 degrees Celsius c) Copan Transystem Amies w/o ch plastic applicator rayon tipped - Manufacturer's storage requirement 5 - 25 degrees Celsius 2. Review of the laboratory's 2024 -- 2 of 7 -- temperature and humidity logs for the area designated as "Urinalysis" revealed the laboratory defined the acceptable room temperature limits as 18 - 30 degrees Celsius which exceeded the manufacturers' acceptable upper limits. 3. In interview on June 25, 2024 at 3:30 p.m., the Quality Assurance Manager confirmed the room temperature limits defined by the laboratory exceeded the limits of the manufacturers as identified above. III. Based on observation, review of the laboratory's temperature records and manufacturer's instructions for use, and interview with personnel, the laboratory failed to define acceptable temperature limits within the manufacturer's required ranges for one (1) of two (2) refrigerators where laboratory supplies are stored in the Blood Bank. Findings: 1. Observation by surveyors during the laboratory tour on June 24, 2024 at 1:22 p.m. revealed the laboratory stored the following supplies in the Helmer refrigerator located in the Blood Bank: a) Ortho Blood Grouping Reagent Anti-D (Anti-RH1) - Manufacturer's storage requirement 2 - 8 degrees Celsius b) Ortho Rh-hr Control - Manufacturer's storage requirement 2 - 8 degrees Celsius c) Ortho Bovine Albumin Solution - Manufacturer's storage requirement 2 - 8 degrees Celsius d) Ortho Reagent Red Blood Cells Affirmagen - Manufacturer's storage requirement 2 - 8 degrees Celsius e) Ortho Reagent Red Blood Cells 0.8% Surgiscreen - Manufacturer's storage requirement 2 - 8 degrees Celsius f) Ortho Confidence System - Manufacturer's storage requirement 2 - 8 degrees Celsius g) Ortho Rho(D) Immune Globulin (Human) - Manufacturer's storage requirement 2 - 8 degrees Celsius 2. Review of the laboratory's 2024 Blood Bank temperature logs revealed the laboratory defined the acceptable temperature limits for the Helmer refrigerator as 1 - 6 degrees Celsius which exceeded the manufacturer's acceptable lower limits. 3. In interview on June 25, 2024 at 9:27 a.m., the Assistant Laboratory Manager confirmed the refrigerator temperature limits defined by the laboratory exceeded the limits of the manufacturer as identified above. D5781