Brookside Women's Medical Services

Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: I. Based on review of the manufacturer's instructions, observation, interview, and patient testing logs, the laboratory failed to perform the Osom Trichomonas Rapid Test correctly when they failed to use the rayon cotton swabs from the test kit for three of three Trichomonas patient tests performed in 2022. Findings follow. A. Review of the package insert for the Sekisui Osom Trichomonas Rapid Test, 11/2021, under Specimen Collection and Preparation stated, "Collect specimens from the vaginal cavity with a sterile rayon swab from the test kit. Use of the swabs supplied in the kit or BD BBL CultureSwab (sterile or with Liquid Stuarts Media) is recommended. Swabs from other suppliers have not been validated. Swabs with cotton tips or wooden shafts are not recommended." B. Surveyor observed on October 21, 2022, at 1600 hours in the laboratory the Sekisui Osom Trichomonas Test kit had 25 rayon swabs in the kit, but only 22 test tubes. The kit was Lot 221122, expiration 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 -- 07/31/2023. C. Interview with testing personnel #2 on the CMS form 209, on October 21, 2022, at 1600 hours in the laboratory acknowledged they ordered swabs in bulk for the clinic and used those for the test. She presented the surveyor with the swabs used for the test, a Puritan Sterile Cotton Tipped Applicator with a wooden shaft. D. Review of the patient testing logs from Jan - Oct 2022 showed three patient tests were performed on 08/04/2022 and 08/31/2022. II. Based on review of the manufacturer's instructions, observation, quality control (QC) records, and interview, the laboratory failed to perform external quality control for the Sekisui Osom Trichomonas Rapid Test for one of one open test kits in 2022. Findings follow. A. Review of the package insert for the Sekisui Osom Trichomonas Rapid Test, 11/2021, under External Quality Control stated, "Minimally, Sekisui Diagnostics recommends that positive and negative external controls be run with each new lot, and with each new untrained operator." B. Surveyor observed on October 21, 2022, at 1600 in the laboratory the Sekisui Osom Trichomonas Test kit had 22 tests remaining out of a kit of 25 tests, and the positive control swab was still in the kit (a rayon swab served as the negative control). The kit was Lot 221122, expiration 07/31/2023, and had no QC information on the box. C. Review of the patient testing logs that included the controls run for various tests from Jan - Oct 2022 showed QC was not performed on the kit. The three patient tests were performed on 08/04/2022 and 08/31/2022. D. Interview with testing personnel #2 on October 21, 2022, at 1615 hours in the counseling room confirmed they only ordered one box at a time, and QC was not performed on the kit. III. Based on review of the manufacturer's instructions, observation, and interview, the laboratory failed to follow manufacturer's instructions for the urinalysis and hCG quality control (QC) testing and use a separate set of vials for the urinalysis and hCG QC. Findings follow. A. Review of the package insert for the Quantimetrix Dipper Urinalysis Dipstick Control Level 1 & 2, under Procedure for Dipstick Testing stated, "Caution Once control fluid is removed for hCG or confirmatory testing that control tube must not be used for dipstick immersion testing. Once a control tube is used for dipstick immersion testing, it must not be used for hCG or confirmatory testing." B. Surveyor observed on October 21, 2022, at 1520 hours in the laboratory two sets of unlabeled QC vials in the box. C. Interview with testing personnel #2 on October 21, 2022, at 1520 hours in the laboratory confirmed they used the same vials for urinalysis and hCG testing. KEY: hCG = human Chorionic Gonadotropin D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 review of the laboratory's textbook procedure, the laboratory's policy and procedure, test reports, pre-survey documents, observation, and interview, the laboratory failed to follow textbook procedure for performing Wet Preps used for the identification of trichomonas, clue cells, and yeast. Findings follow. A. Review of the laboratory's textbook procedure from Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd Edition, 1990, Chapter 179, Tests on Vaginal Discharge, under Technique stated, "Place the sample in 1 ml of saline and agitate to mix. Take a drop of this mixture and place it on a slide... cover with a cover slip.... The slide may be warmed briefly (to increase motility of trichomonas) and should be -- 2 of 3 -- looked at promptly. A careful search of several fields should be made at both medium and high power for trichomonas, clue cells, and yeast. Trichomonas are motile flagellated organisms about the size of a white blood cell (WBC). They are best recognized by their characteristic twisting motion. Clue cells are vaginal epithelial cells with adherent coccobacilli. Yeast may be seen as budding or hyphal forms, and may be seen best with the addition of potassium hydroxide. Lastly, the presence or absence of a large number of leukocytes should be noted. A few may be normal, but more than 10 per high-power field is abnormal. An additional [drop] should be ... placed on a slide. Add a drop of 10% potassium hydroxide (KOH) and cover with a cover slip... The slide should then be examined carefully for the presence of budding yeast or hyphae. The pH of the vaginal secretions can be obtained by placing a sample from the lateral wall of the vagina on pH paper. The paper should include a range of pH from 4.0 to above 5.0. The normal pH is 4.5 or less. The whiff test is a test for the fishy odor that occurs in bacterial vaginosis (previously called Gardnerella vaginitis and nonspecific vaginitis). A drop of KOH is mixed with some vaginal discharge. A positive test is abnormal and consists of a characteristic fishy odor." B. Review of the laboratory's policy and procedure titled, Wet Prep/Mount stated, "1. During the exam, the doctor (or nurse, medical assistant, etc,) will collect a small amount of the patient's vaginal discharge using a non-sterile cotton swab. 2. Place the sab into a centrifuge tube and take it to the lab for evaluation. 3. Rub the swab on a small amount of pH paper to determine the pH level. 4. With the swab in the tube, add 3-4 drops of saline. 5. Mix the swab around in the saline to moisten the specimen. 6. Rub the swab on a slide. 7. Place a cover slip on top. 8. Evaluate the slide under the microscope for yeast, bacterial vaginosis (clue Cells), trich, and white blood cells. 9. After the microscopic evaluation, add 3-4 drops of KOH (Potassium Hydroxide) to the saline and swab. 10. Mix again and sniff the swab for the "whiff test." A strong ammonia-like odor indicates a POSITIVE result. No odor indicates a NEGATIVE result. 11. Use the 'Wet Smear' stamp to record these findings in the patient's chart, the third page of the 'History and Physical' form." The laboratory's current procedure may inhibit testing personnel from identifying microorganisms. C. Review of the test reports for Wet Prep showed results for four out of five patients had the following results for the Wet Prep: Collection date Results for: Trichomonas, clue cells, and yeast 1. 09/08/2022 uta uta uta 2. 08/04/2022 uta uta uta 3. 08/04/2022 uta uta uta 4. 3/21/2022 uta uta uta The fifth test report had the following results: 5. 08/31/2022 Neg uta uta D. Review of the pre-survey document Annual Test Volume & Proficiency Testing Programs Worksheet showed an estimated 50 Wet Preps were performed annually. E. Interview with testing personnel #2 on October 21, 2022, at 1630 hours in the counseling room confirmed the laboratory director does not do wet preps, only pH and Whiff tests were done, and reported under the Wet Prep test report. KEY: ml = milliliter uta = unable to attain -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, observation and interview, the laboratory failed to label their Saline vial, used to test Wet Prep solutions for the identification of clue cells, yeast, and trichomonas, to include lot number, pour over date and expiration date, as applicable. Findings follow. Review of the laboratory's Wet Mount (Prep) procedure on page 2 stated, "Normal saline and KOH solutions must be replaced monthly. Each new bottle must be labeled with the name of the solution and the expiration date." Surveyor observed on March 9, 2021 at 1030 hours in the laboratory a vial labeled "Saline" on the counter next to the microscope. Interview with testing personnel #1, on the CMS form 209, on March 9, 2021 at 1030 hours in the laboratory confirmed the Saline was used for Wet Preps and was missing any additional information. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units 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 -- of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, patient test reports and interview, the laboratory failed to include all the results of the Wet Prep used for the identification of clue cells, yeast, and trichomonas for 1 of 3 test reports reviewed. Findings follow. Review of the laboratory procedure Wet Mount (Prep) stated, "a wet mount test provides a fast and convenient method for screening for vaginal infections such as yeast, trichomonas, and bacterial vaginosis." Review of the Wet Prep patient test reports showed a test report from 03/09/2021 was missing the results of "Monilla" for yeast and Clue Cells. Interview with testing personnel #1, on the CMS form 209, on March 9, 2021 at 1145 hours in the office confirmed the results were missing on the test report. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Review of the CMS report 209 Laboratory Personnel Report, personnel files and interview of facility personnel found that the technical consultant failed to perform competency assessments at least semiannually during the first year of patient testing for one of 11 testing personnel performing Rh testing. Findings were as follows: 1. Review of the The CMS report 209 Laboratory Personnel Report found the laboratory listed 11 testing personnel performing non-waived testing. 2. Review of personnel files found that testing person four had an initial hire date of 09/04/2019. Testing person 4 completed initial training for Rh testing on 09/04/2019. One competency assessment dated 04/02/2020 was included in the personnel file with no other competency assessments available for review 2. Interview of testing person one conducted on March 9, 2021 at 10:30 AM confirmed that competency assessments for testing persons 4 were not performed at least semiannually during the first year of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, training documentation for testing personnel, and staff interview, the laboratory director failed to ensure that 1 of 11 testing personnel for the moderately complex test systems had documentation of qualifying education prior to performing patient testing. The findings included: 1. Based on review of laboratory policy "Laboratory Director", on page 4, the document states the following: "10. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities;" 2. Based on review of personnel files, Testing Person 10 (1 of 11 Testing Persons) did not have documentation of credentials 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 -- that met the requirements for moderate complexity testing at 42 CFR 493.1423. Refer to D6065. 3. In an interview at 10:53 hours on 10/18/2018, the Office Manager confirmed the findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the CMS-209, laboratory policies and procedures, personnel records, and staff interview, the laboratory failed to ensure that 1 of 11 testing personnel met the qualification requirements at 42 CFR 493.1423 by having the appropriate education required to perform moderate complexity testing prior to analyzing patient specimens (refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, training documentation for testing personnel, and staff interview, the laboratory failed to ensure that 1 of 11 testing personnel for the moderately complex test systems had documentation of qualifying education prior to performing patient testing. The findings included: 1. Based on review of laboratory policy "Laboratory Director", on page 4, the document states the following: "10. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities;" And; Based on review of the laboratory policy "Testing Personnel Qualifications and Responsibilities", the document states the following: "The testing personnel must meet one of the following qualification requirements regarding education, training, and experience: 1. M.D. or D. O. with a current medical license in the state of the laboratory's location. OR 2. Doctorate in laboratory science or chemical, physical, or biological science. OR 3. Masters in medical technology or chemical, physical, or biological science. OR 4. Bachelors in medical technology or chemical, physical, or biological science. OR 5. Associate degree in chemical, physical, or biological science or medical laboratory -- 2 of 3 -- technology. OR 6. High school graduate or equivalent and successfully completed military training or 50 or more weeks and served as a medical laboratory scientist. OR 7. Academic high school diploma or equivalent and appropriate training/experience for the test performed prior to analyzing client specimens. (See Training Section for specific requirements)." 2. Based on review of personnel files, Testing Person 10 (1 of 11 Testing Persons) did not have documentation of credentials that met the requirements for moderate complexity testing at 42 CFR 493.1423. The documentation for review indicated Testing Person 10 had a Bachelor of Arts with Distinction in German. 3. In an interview at 10:53 hours on 10/18/2018, the Office Manager confirmed the findings. -- 3 of 3 --