Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor observation and staff interview, the laboratory failed to ensure positive identification of a patient's specimen from the time of collection through completion of testing. Findings include: 1. Surveyor observation on 3/21/19 at 11:00 AM of the laboratory work bench area revealed the following: a. A cone shaped piece of styrofoam located on the laboratory work bench. b. Testing personnel #2 (TP2) performed a rapid strep test and stuck the stick side of the patient's throat swab into the side of the styrofoam cone. The swab was not labeled. TP2 set a timer and walked away from the bench while the rapid strep test was in progress. c. Testing personnel #3 (TP3) performed a rapid strep test and stuck the stick side of the patient's throat swab into the top of the styrofoam cone. The swab was not labeled. TP3 set a timer and walked away from the bench while the rapid strep test was in progress. 2. Staff interview on 3/21/19 at 11:05 AM with the testing personnel #1 (TP1) confirmed swabs are not labeled with any patient identifier and they are left unattended in the styrofoam cone until planted. TP1 confirmed at times multiple unlabeled swabs can be left in the styrofoam cone until planted. 3. The laboratory performs 582 throat cultures annually in the subspecialty of bacteriology. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor observation, record review, and staff interview, the laboratory failed to follow established laboratory safety procedures. Findings include: 1. Surveyor observation on 3/21/19 at 11:00 AM revealed, testing personnel #2 (TP2) performed a rapid strep test and planted a throat culture without wearing gloves. 2. Record review on 3/25/19 of the laboratory's, 'Model Exposure Control Plan For Avon Pediatrics,' procedure revealed: a. Form 5.1, 'General Requirements on Personal protective Equipment', #3, "Employees shall wear appropriate gloves when it can be reasonable anticipated they may have hand contact with Blood, or other infectious materials, mucous membranes, non-intact skin, and when handling or touching contaminated items or surfaces." b. Form 5.3, Employer Policy Statement for Use of Gloves', #1, "Gloves are to be worn at any time when there is potential for direct contact with blood or other potentially infectious body fluids or materials." 3. Staff interview with testing personnel #1 at 11:05 AM confirmed the findings in #1 above. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to follow the manufacturer's instructions in the subspecialty of bacteriology. Findings include: 1. During observation on 3/21/19 at 11:30 AM of the bacteriology testing area, surveyor observed testing personnel #2 planting a throat swab on a Strep Select Agar (SSA) plate. 2. During observation on 3/21/19 at 11:30 AM of the incubator used for throat culture testing, surveyor noted the following: a. Three SSA plates were located inside the incubator. b. Two of the 3 plates referenced above were cold to the touch. 3. Record review on 3/21/19 of the manufacturer's package insert for SSA media revealed: a. "Allow unopened plates to warm to room temperature prior to inoculation." b. "The ability to detect microorganisms by culture techniques can be affected by the following factors: improper specimen collection, storage and inoculation, initiation of antiinfective therapy prior to specimen collection, improper culture incubation temperatures and atmospheres, improper length of culture incubation, and improper storage and handling of culture media." 4. Staff interview with testing personnel #1 on 3/21/19 at 11:30 AM confirmed the above findings. D5781